SCAM ALERT: ZAAZ WHOLE BODY VIBRATION Markets their vibrating machine as FDA approved and Nasa technology. Well, it’s not FDA approved. I spoke to FDA today and also received an e-mail from them. The product is an exercise machine not a medical device. It’s made in China not Canada. On their website http://zaazstudios.com/faq/ they claim the following:
“ZAAZ machines are FDA approved at registration #3007722048 and are also approvedby Health Canada as an exercise machine and a medical device. Recent additions to our lineup may still be in the FDA approval process.”
Please look at this link from FDA regarding registration #3007722048 :
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/LDetails.cfm?LID=183474
Registration number 3007722048 is for a powered nasal irrigation devise.
I notified FDA and received a letter back confirming that ZAAZ Machines are not FDA approved and misbranded.
The Letter Reads:
BEGINNING OF LETTER
"Thank you for contacting the Food & Drug Administration’s Division of Small Manufacturers, International and Consumer Assistance (DSMICA). We appreciate your diligence in alerting us to the issues raised in your email. I have included detailed discussions on “cleared vs. approved,” determining a medical device’s clearance or approval status, determining prescription/restricted/over the counter use, sales of prescription/restricted use devices, and online sales. It is advisable that you pay particular attention to the discussion regarding References to FDA in Labeling and Marketing.
I conducted a brief search in the FDA Registration & Listing Database, and “3007722048” appears to be the Registration Number matching a company named "T-Zone Vibration Technology:
This appears to be an entry for a Canadian company listed as a Specification Developer and Foreign Exporter to the United States of a Class I (low risk), Product Code BXB, 510(k) exempt, GMP non-exempt medical device. Note that a low risk medical device is not “FDA Approved” …
References to the FDA in Labeling and Marketing:
Since 510(k) Clearances are for lower to moderate risk devices, the labeling of such devices as “FDA approved” (reserved for high risk devices) is misleading and constitutes misbranding (FD&C Act, Sec 502). Per the actual text in the US Food Drug & Cosmetic Act, Sec. 502 (21 U.S.C., Chapter V, Section 352):
A drug or device shall be deemed to be misbranded–
(a) False or misleading label. If its labeling is false or misleading in any particular.
Thus, a claim that a device requiring a 510(k) (low to moderate risk) is “FDA Approved” (high risk) is misleading and prohibited."
*** END OF LETTER***
These vibration machines are an updated version of the CRAZYFIT branded Vibrating machines sold for $200. These machines cost less than $100 from the manufactures in China. Don’t get SCAMMED for over $2000 for these machines. THE SELLING POINT is that they are FDA approved, AND THEY ARE NOT!!! FDA is looking into the matter right now.
If you have already purchased this machine, you should call FDA and notify them of the false advertising.
Owner of the company lives in Canada.
My issue is: you can sell it for whatever price you wish to sell it for, but don’t claim it’s FDA approved to help you make the sale. There are other vibrating machines out there you can purchase between $200-$800.
Don’t believe me? Do your own homework before purchasing this machine, CALL FDA and verify for yourself or write them an e-mail.