Kegel Master Product Review: KegelMaster 2000 vs Kegel Exerciser Battle Showdown

The Kegel master story continues to swirl with endless controversy. Kegelmaster 2000 has been on the market for more than 4 years before a product redesigned in 2002 gave them FDA clearance.

kegel exercise

But clearance for what?

In November 2004 the FDA issued a Kegel Master manufacutring and marketing a warning letter.

Kegal Master 2000 founder David Warick was cited on numerous violations.

Including false advertising.

Here is a sample of the letter:

H. David Wallick, CEO Kegelmaster 2000 Ltd. 4722 Camphor Avenue Sarasota, Florida 34231

Dear Mr. Wallick:

During a Food and Drug Administration (FDA) inspection of your establishment located in Sarasota, Florida, on August 6, 2004, an FDA Investigator determined that your firm manufactures the Kegelmaster 2000.

The Kegel master 2000 is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), and was cleared by FDA in 2002 for assisting women in the performance of Kegel exercises, which may help control stress urinary incontinence.

The above-stated inspection revealed that your devices are adulterated and misbranded under the Act for the reasons set forth below...

...The above stated inspection also revealed that your device is misbranded under section 502(a) of the Act in that the labeling for the device is false and misleading.

The carton label states, “Tested and Approved by U.S. Department of Health and Human Services FDA Food and Drug Administration”.

The instruction manual reads, “Tested and Approved by the FDA”.

These statements are false and misleading because the device is not approved by FDA.

Clearance for marketing your device through 510(k) premarket notification process does not in any way denote official approval of the device and any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding as described in 21 CFR 807.97