Many physicians and chiropractors are now investigating new sources of therapy and among the new technologies offered, the Bio-Flex Laser Therapy is a new alternative. Muscle and tissue conditions as well as accelerating the healing of broken bones are some of the areas where this product could prove to be effective. The entire process for one session is completed in around 15 minutes. BioFlex has been cleared by the FDA as well as by Health Canada. Basic training will require 2 days to be certified on the use of low intensity laser therapy. 
The site provides a listing of facilities and clinics currently using the BioFlex laser technology. Some typical conditions being treated with laser therapy include but are not limited to rotator cuff tear and repetitive stress injury. The site also offers some case studies where the technology is currently in use. Several professional sports organizations have also been using the BioFlex Laser. BD
"What is Laser Therapy? Laser therapy is the use of monochromatic light emission from a low intensity laser diode (250 milliwatts or less) or an array of high intensity super luminous diodes (providing total optical power in the 1000-2000 milliwatt range). Conditions treated include musculoskeletal injuries, chronic and degenerative conditions and wounds. The light source is placed in contact with the skin allowing the photon energy to penetrate tissue, where it interacts with various intracellular biomolecules resulting in the restoration of normal cell morphology and function. This also enhances the bodys natural healing processes."
The web site also offers a series of videos containing both educational material as well as some recent press coverage.
Follow the links below for additional information.
Meditech International - Home Page
What Is Low Intensity Laser Therapy?
Note that, per the current fda.gov site, the FDA issued a Warning Letter on May 4, 2004 to the firm marketing the Super Nova that it had approved in its K001179. Their Warning Letter took issue with several statements in that firm’s marketing literature including, “wonderful for conditions like tennis elbow, nerve pain, (and) tension headache..” and “helps relieve pain from tendonitis (and) bursitis” Therefore, we suggest you contact the FDA directly concerning the admissibility of your product. Per that FDA letter of May 4, 2004, the marketer of the Super Nova was directed to William Defibaugh at (301) 594-4660, extension 121, for specific questions on FDA requirements on that product and to their Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2042, for more general information.
ReplyDeleteFebruary 23, 2005
ReplyDeleteCLA-2-90:RR:NC:N1:105 R01356
CATEGORY: CLASSIFICATION
TARIFF NO.: 9018.20.0040
Mr. Damon Douglas Piatek
Northern Customs Services Inc.
6391 Walmore Road
Niagara Falls, NY 14304
RE: The tariff classification of a Low Intensity Laser Therapy System (The BioFlex System) from Canada
Dear Mr. Piatek:
In your submissions dated November 15, 2004 and January 26, 2005, for Meditech International Inc., you requested a tariff classification ruling. No samples were submitted.
Per the cover of the Meditech flyer you sent, your item is a BIOFLEX LOW INTENSITY LASER THERAPY SYSTEM, PROFESSIONAL UNIT, FDA APPROVED. Its Medical Applications are stated to include Tendonitis, Tennis Elbow, Fibromyalgia, Carpal Tunnel Syndrome, and Herniated Disc. It is clear that it is not intended for home use due to its complexity and cost.
Four of the six treatment heads have only LEDs (Light Emitting Diodes) and the other two have low intensity (Level III b) LDs (Laser Diodes.) These LDs are far weaker than the ones used by surgeons in making incisions or plastic surgeons in hair removal, etc. The system includes capabilities of selecting among various routines for timing and pulsing the lights and for recording electronically session/patient data.
You did not dispute our statement in our December 22, 2004 letter to you that the lack of coherence of the light from the LEDs precluded it from being considered laser light (whether on not pulsed on and off.) We also note that the light of the LEDs has a wide Effective Surface Area, 25 to 75 square centimeters, per the flyer, which is several hundred times wider than that typical for lasers.
You did provide a copy a copy of the FDA approval documentation in response to our request.
In their K023621, dated April 10, 2003, the FDA approved the BioFlex Professional Therapy, US Version as an Infrared Lamp under its Regulatory Class II. Meditech had claimed that it was substantially equivalent in performance to the Super Nova approved in FDA K001179. Per the information you supplied, each of the six heads does emit a substantial part of its light in the Infrared or Near Infrared portion of the spectrum.
Per Exhibit 2 to K023621,
“Indications for Use
The BioFlex Professional Therapy System is used by trained health care professionals and is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.
We note that, per the current fda.gov site, the FDA issued a Warning Letter on May 4, 2004 to the firm ... Their Warning Letter took issue with several statements in that firm’s marketing literature including, “wonderful for conditions like tennis elbow, nerve pain, (and) tension headache..” and “(relieves pain from tendonitis bursitis” Therefore, we suggest you contact the FDA directly concerning the admissibility of your product.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at 646-733-3012.
Sincerely,
Robert B. Swierupski
Director,