Biofirst patch

│ Quick Information │

• Model Number : CWH-100

│ Description │

FDA Certification of Registration
-Establishmnet Registration : 3003958502
-Regulattion Number : 890.5710

Selling pharmacy in Danver Selling pharmacy in Marblehead

│ Features │

The Biofirst Patch is made using Far Infrared Rays(FIR) ceramics such as tourmaline, illite and jade. It emits FIR and negative ions.
The combination of FIR and negative ions improves the blood-circulation of the human body and stimulates the natural healing process.
The Biofirst Patch is easy to apply and provides fast and effective relief.

•Pain relief technology using natural ingredients to provide long lasting deep penetrating relief through the use of Far Infrared Ray.
•Wear unnoticed under clothing day or night.
•No pills, creams or embarrassing orders.
•Breathable.
•Water Resistant.

│ Effectiveness │

Quick and effective for pains in back, shoulder, neck, and muscles, paralysis, insomnia, neuralgia and abnormal nerve function.

•Improves micro-blood circulation
•Improves vitality and heart functions
•Relieves stress and fatigue
•Improves vitality
•Effective in killing bacteria and fungi
•Removes odors and wipes out fungus
•Enhances and maintains freshness
•Maintains warmth for better sleep
•Improves homeostasis

│ Indication │

Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains.

│ Directions │

•Adults and children 12 years and over: apply to affected area: change pad daily.
•Children under 12 years: consults a doctor
•How to apply
- Clean and dry skin area
- Remove patch from package
- Peel protective film from back
- Apply Patch directly to site of pain
- Change patch location to prevent skin irritation

│ Warnings │

For External Use Only
•Use only as directed
•Avoid contact with eyes, lips, or nose.
•Discontinue use if excessive redness, burning or discomfort of skin develops. if pain worsens or persists for more than 7day or clears up and consult a doctor.
•Do not bandage tightly or cover with any type of wrap except clothing.
•Do not apply to open wounds, damaged or irritated skin.

KEEP OUT OF THE REACH OF CHILDREN AND PETS.
•If swallowed, get medical help immediately.

│ Test Result of BIOFIRST PATCH │

1) Emissivity and Emissivity Energy(FIR)
The experimental results were measured in comparison with black body by using the FT-IR Spectrometer.

EMISSIVITY (5 ~ 20μm)	EMISSIVITY ENERGY (W/m2μm, 37°C)
0.912	3.52 x 102

Measured by the Korea Far Infrared Ray Association as the official test organization

2) Negative Ion
The experiments were conducted using ION analyzer at the conditions of temperature 22°C, and humidity 46% and anion number 106/cc of the atmosphere, anion discharge from Specimens was measured and results were shown anion number per unit volume.

SAMPLE	NEGATIVE ION (ion/cc)
BIOFIRST PATCH	550

Measured by the Korea Far Infrared Ray Association as the official test organization

3) Clinical Effect(Blood Velocity)
The Purpose of this study is to evaluate the clinical effect of Biofirst Patch the peripheral arterial flow of human body.
Peak flow velocity of blood means the point of maximum flow of blood per unit time(cm/sec). So we consider the increase of peak flow velocity as the increase of blood amount to the tissue clinically. And mean velocity of blood is the average result of several beats of blood flow per unit time. The clinical implication of mean velocity of blood is more important than that of peak velocity. When we applied the Biofirst Patch to the specimen, we found the increase of mean velocity of blood, which was measured by doppler. The change of heart rate was not significant(Mean blood velocity was increase as 5.6 to 9.1cm/sec(63% over).

Before applying Patch

After applying Patch

Measured by the Eulji Univ. Hospital Daejeon Korea

4) Kirlian Effect(Chi, Vitality, Bio Energy)
• Two pictures show the Chi-image of four fingers before and after the Biofirst Path attached on the arm.
• The pictures were shown that the Chi energy emitting from four fingers after attached the Biofirst Patch was about 3 times than that of before the attached Biofirst Patch.

Before applying Patch	After applying Patch

Measured by the Korea Research Institute of Jungshin Science

5) Bio information Resonance System analysis(BRS)
• Using bio-resonance(feedback) from body system, this machine looks at over 4,000 substances that may be causing problems. The machine is able to scan and treat the resonance, current and energy of the body own bio-electrical system.
• This bio energy is produced within the cells of your body through their own electrical activity.

Items		Before	After	Change(%)
Increase homeostasis	B222	+5	+10	100
Decrease stress	F009	+7	+9	29
Increase blood circulation	F543	+5	+10	100
Decrease pain	D468	+6	+8	33
Decrease inflammation	D372	+7	+8	14

Measured by the Korea Research Institute of Jungshin science

6) Thermovision Studies of BioFirst Patch
•Thermovision studies of Biofirst Patch was measured using Infrared Ray thermovision system at room temperature 22°C, humidity 44%.
•The data was explained image and temperature data to emitted infrared ray energy at the substance. and high temperature promote blood circulation
• Biofirst Patch has Far Infrared Ray(FIR) energy. and FIR have the ability to penetrate deep into the human skin. Once this penetration occurs, resonance begins, causing molecules to vibrate rapidly against each other. This vibration releases attached toxins, allowing them to be expelled from the body.

General Patch without FIR	BioFirst Patch with FIR

Measured by the Korea Far Infrared Ray Association as the official test organization.

Before applying Patch	5min after applying Patch

Measured by the Korea Far Infrared Ray Association as the official test organization.

7) Anti Bacteria
•The blank test was measured on non-test sample.
•The bacteria number on the petri dish was detected by multiplication of dilution rate.
•Test Method : KS K 0693-2000
•Refer to the Enclosed

Staphylococcus aureus ATCC 6538.

General Patch	BioFirst Patch

Klebsiella pneumoniae ATCC 4352.

General Patch	BioFirst Patch

Measured by the Korea Far Infrared Ray Association as the official test organization.

8) Change of Erythrocyte

Before Applying Patch	30min after putting off BioFirst Patch

Measured by the Korea Far Infrared Ray Association as the official test organization.

9) Change of Brain Wave(Alpha wave)
* T1 : 5min after applying BioFirst Patch
* T2 : 30min after applying BioFirst Patch
Measured by the Korea Far Infrared Ray Association as the official test organization.

10) Case study analysis(24case)
CHICAGO PAIN &REHABILITATION CENTER
7300 North Cicero Avenue . Lincolnwood, Illinois 60646, USA

• Case 1.
  

  Patient Name	Kim, Ok boon, Female, 47
  Diagnosis	Elbow pain due to lateral epicondylitis
  Duration of pain	3 months
  Duration of using patch	7days
  Level of pain	10 = severe pain 0 = free of pain
  Before Treatment	Level 8
  After Treatment	Level 3

  
  Analysis:
  Our patient, Ok Boon Kim suffered from elbow pain due to lateral epicondylitis for a duration of 3 months. She had moderately high level of pain at 8 at the time of her evaluation. This particular patient has used other products that offer the same type of pain relieving effect so as a result, she was curious as to the performance of this particular patch.
  She applied the patch daily for the duration of 7 days. One key element of the patch that she emphasized as a positive was the fact that the patch was small and could be placed conveniently just about anywhere. She was quoted as saying "the size of th patch enables the patch to fit anywhere." What impressed her was the effect of the patch even though the patch was of a smaller size as compared to the others that she had tried. She had good responses to the patch and felt impact of the patch on the first day as well. The heat generated from the far infrared rays did not provide any discomfort, rather, was considered to be a primary positive characteristic of the patch. She did not complain of any excessive heat emission and felt quite comfortable throughout the duration of the trial period. The smell of the patch had no effect on her in ant way, both positively and negatively.
  The patient considered the smell a mute point as far as she was concerned. As her pain continued to decrease throughout the 1 week period, her comfort level with her elbow increased on a daily basis to the point where her pain dropped to a level of 3. She did not suffer from any adverse effects from the use of the patch.
  
  
• Case 2.
  

  Patient Name	Ha, Sun Jeong, Female, 17
  Diagnosis	Ankle pain due to MVA
  Duration of pain	2 weeks
  Duration of using patch	7days
  Level of pain	10 = severe pain 0 = free of pain
  Before Treatment	Level 9
  After Treatment	Level 3

  
  Analysis:
  Our patient, Sun Jeong Ha suffered from ankle pain due to MVA for a period of 2 weeks. Her pain was at a high level of 9 at the time of her initial evaluation, which took place shortly after her accident. She applied the patch daily for a period of 7 days and the results were signigicant. As the ankle is a sensitive area, she immediately felt the impact of the patch on the first day of application. She had a good response from the effect of the patch throughout the duration of the trial period. She did not complain of over heating from the far infrared rays found the and patch to be quite comfortable not only in convenience, but also in the direct treatment of the patch to her area of pain on her ankle. In actuality, she really enjoyed the small of the patch. She commented on the fact that the smell of the patch was really soothing. As a result, the smell did not alter her overall positive impression of the patch. Her condition improved tremendously over the 1 week period to the point where her pain level dropped to a level of 3. She did not suffer from any adverse effects from the use of the patch.
  
  
• Case 3.
  

  Patient Name	Pyune, Chun Ja, Female, 75, 140 lbs., 160 cm.
  Diagnosis	Knee pain due to degenerative arthritis
  Duration of pain	2 years
  Duration of using patch	7days
  Level of pain	10 = severe pain 0 = free of pain
  Before Treatment	Level 8
  After Treatment	Level 4

  
  Analysis:

Our patient, Chun Ja Pyune suffered from knee pain due to degenerative arthritis for 2 years. Her pain was severe with severe with a level of 8 as she had been suffering from this pain due to the chromic nature of it. However, her pain decreased significantly to a surprisingly moderate level of 4 after 1 week trial period. The immediate impact of the patch was experienced by the patient on day 1 of use and continued to consistently decrease each day thereafter. The patient did not experience any adverse effect from the use of the patch.
Comments from patient : "The patch was really great because even when taking a shower, the patch did not fall off"

• Case 4.
  

  Patient Name	Cho, Kye Hui, Female, 81,
  Diagnosis	Low back pain due to lumbar strain
  Duration of pain Duration of using patch	5 days 5 days
  Level of pain	10 = severe pain 0 = free of pain
  Before Treatment	Level 9
  After Treatment	Level 4

  
  Analysis:
  Our patient, Kye Hui Cho suffered from low back pain due to lumber strain for a duration of 5 days. Her pain was quite severe at a level of 9 at the time of her evaluation. We had her apply 2 patches covering the region of her pain for a period of 5 days. Upon application of the patches, she did not experience any pain relief until the second day of application. She began to feel much better on the second day and the pain continued to decrease each day thereafter. She felt quite comfortable with the infrared rays and the heat that was emitted. She found that it was very soothing and at the same time, very intense. The smell of the patch was not of any significance to her, both positively and negatively. Her pain eventually dropped to a level of 4 following the 5th day of application and she was very satisfied with the effectiveness of the patch. She also found the patch to be very convenient in size and durability. She did not suffer from any adverse effects from the use of the patch and as an elderly patient, the non existence of any rashes or any other types of allergic skin reactions was a significant positive characteristic both during the use if the patch and after the completion of using the patch. Overall, she was very impressed with the performance of the patch.
  

 

│ Specifications │

- Model Name : Biofirst Patch(Natural Pain Reliever Patch, CWH-100)
- Patch Size : 10 x 8cm, 6 patches in box
- Box Weight : 31g
- Korean Patent