Kegelmaster Product Review
The Kegelmaster story continues to swirl with endless controversy. Kegelmaster 2000 has been on the market for more than 6 years before
a product redesigned in 2002 gave them FDA clearance.
Click Here For Kegelmaster 2000 Product Details
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
Read the full FDA KegalMaster Letter here.
The website has been updated to say that the kegal master is constructed
with:
"100% FDA Approved
Medical Grade Materials"
You can view the kegel
master product comparison to the Kegel Exerciser
FeminX™( discontinued product as of 2007) on the kegel master website.
This is where the FDA cited the violation.
The Kegel Master product battle between Kegalmaster 2000 and Kegel
Exerciser
FeminX™ is hot - very hot!!!
Neither one is innocent of bad taste in marketing - you
can read my full review on these product here.
Spelling Variations: Kegal, Kegalmaster, Kegal master
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