Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

 

2098 Gaither Rd
Rockville, MD 20850

June 19, 2001
WARNING LETTER
VIA FACSIMILE AND FEDERAL EXPRESS

Steven Daffer, President
Symedex Medical Aesthetic Solutions
9220 James Ave S
Minneapolis, MN 55431

Ref. No. MD2000 and MD2 Therapeutic Massagers

Dear Mr Daffer:

The Promotion and Advertising Policy Staff (PAPS), Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed the June 5 response from Mr Ronald E. Berglund, Symedex Medical Aesthetic Solutions (Symedex) General Counsel, to our letter dated May 1. Our letter was in regard to the MD2000 and MD2 Therapeutic Massagers. We find Mr. Berglund's response on your behalf unacceptable.

The MD2000 Therapeutic Massager and the MD2 Therapeutic Massager are classified by regulation under Title 21, Code of Federal Regulations, Part 890.5660 [21 CFR 890.5660] as therapeutic massagers and are also devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

Claims for therapeutic massagers are currently limited by the agency to the following:

  1. temporarily relieves minor muscle aches and pains caused by fatigue or overexertion;
  2. temporarily increases local blood circulation;
  3. relaxes muscles locally;
  4. relieves DOMS (delayed onset muscle soreness);
  5. relieves minor muscle aches and pains, relieves muscle spasms, and temporarily improves local blood circulation during burn rehabilitation;
  6. temporarily reduces the appearance of cellulite and circumferential body measurements of cellulite treated areas.

The modifications recently made to your website at the internet address www.symedex.com remain unacceptable because statements appearing on your site continue to claim and/or imply that your therapeutic massagers (MD2000 and MD2) play a role in the treatment of liposuction, that use of these devices can affect interstitial edema, fat hypertrophy, and lipolymphedema, and/or that they can be utilized in medical settings including pre-surgery, intra-operative surgery, and in post-surgical applications. Additionally, your website names the treatment heads for the MD2 as "lipoapplicator heads" and identifies some of the MD2 inclusion accessories as "Smooth Lipoapplicator (MD229)," "Mini Prong Lipoapplicator (MD225)," and "Liposculpt Therapeutic Cream." These claims imply that the MD2000 and/or MD2 may be used in the treatment of liposuction, reduction of edema, or for pre, intra, and post surgical conditions. None of these claims has been cleared by the agency.

Other representative examples of unacceptable claims appearing on your revised website include the following:

Additionally, your page titled, Cellulite Reduction, mentions the physical and physiologic changes that occur in capillaries and superficial fatty tissues such as interstitial edema, fat hypertrophy, and Iipolymphedema. By discussing these physiologic changes in conjunction with the MD2000 System, Symedex implies that your therapeutic massager can treat these conditions, which it has not been cleared for.

Your website also includes testimonial statements from several physicians and includes study results that suggest the MD2 and MD2000 may be used as an adjunct in the treatment of liposuction. Representative statements include, but are not limited, to the following:

From an article by Paul Rose, MD, (consultant for Symedex) titled "A Preliminary Study of the Effect of Percussive Massage in Post Liposuction Patient Recovery"
From a testimonial by Edward M. Zimmerman, MD, reporting his initial experience with the A4D2000 and MD2 as an adjunct to tumescent liposuction
From Paul Rose, MD, in a March 9, 1999 letter to Ron Berglund, Symedex General Counsel
From Gregory W. Chernoff, MD, in a December 29, 1999, letter to Steve Trinter, Symedex National Sales Manager
From Mark L. Zukowski, MD, in a March 8, 1999, letter to Ron Berglund, Symedex General Counsel

In our letter of January 18, you were previously advised that certain claims which appeared in your advertisements and on your website went far beyond those recognized by the agency for therapeutic massagers and removed your MD2000 and MD2 devices from exempted status. The claims for which you were previously cited included:

From an advertisement: From the Internet:

As is evident from the above claims, Symedex continues to include some of these identical claims on its current website despite prior notice that those claims were inappropriate. FDA regulations at 21 CFR 801.4 refer to the objective intent of the persons legally responsible for the labeling of the device.

Promotion of the MD2000 and MD2 Therapeutic Massagers for the claims on your current website causes these devices to be misbranded within the meaning of section 502(o) of the Act, in that a notice or other information respecting the modification in the intended use of the devices was not provided to FDA as required by section 510(k) of the Act and the devices were not found to be substantially equivalent to a predicate device.

The MD2000 and MD2 Therapeutic Massagers are also adulterated within the meaning of section 501(f)(1)(B) of the Act in that they are Class III devices under section 513(f), and do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a), or an approved application for investigational device exemption (IDE) under section 520(g).

We also note that your website discusses the use of a "Fotostation Photo Image Measurement System." The system is described as documenting before, during, and after progress following use of the MD2. We believe these references allude to weight loss or loss of inches and we caution Symedex that any such claims for your MD2 and MD2000 have not been cleared by the agency.

Finally, we see that Symedex has scheduled several training sessions from the present through the end of the year (2001) regarding the use of the MD2 and the MD2000 Systems. We caution Symedex that these devices may only be demonstrated, and potential customers trained, for the claims granted by the agency and identified in paragraph 3 of this letter.

This letter is not intended to be an all-inclusive list of deficiencies associated with the products you are promoting. It is your responsibility to ensure adherence to each requirement of the Act and Federal regulations. The specific violations noted in this letter may represent practices used in other promotion or advertising materials used by your firm. You are responsible for investigating and reviewing these materials to assure compliance with applicable regulations.

You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

Please notify this office, in writing, within 15 working days of receipt of this letter, outlining the specific steps you have taken to correct the cited violations. Your response should also include all steps being taken to address misleading information currently in the market place and actions to prevent similar violations in the future. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to Ms Patricia L. Jahnes, Consumer Safety Officer, Promotion and Advertising Policy Staff (HFZ-300), Office of Compliance, Center for Devices and Radiological Health, 2098 Gaither Rd, Rockville, MD 20850.

A copy of this letter is being sent to FDA's Philadelphia District Office. Please send a copy of your response to the District Director, Food and Drug Administration, Philadelphia District Office (HFR-CE100), US Customhouse, 2nd & Chestnut Sts #900, Philadelphia, PA 19106.

Sincerely yours,
/s/
Deborah A. Wolf for
Larry D. Spears
Acting Director, Office of Compliance

This page was posted on August 20, 2006.

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