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Zona Plus and The Blood Pressure Cure

Written by: Dr. Rowena | Posted: Jan 14 2009

Q: What is your knowledge or experience with the efficacy of
Kowalski’s Blood Pressure Cure (book + supplement regimen) or the Zona Plus - a device that supposedly can lower blood pressure?

A: In his book, Kowalski promotes healthy lifestyle changes that are keys to good blood pressure control and heart disease prevention. However, the use of supplements is always controversial. You should discuss their use with your health care provider. The Zona Plus is a device that claims to lower blood pressure by a computer guided hand gripping exercise. Unlike the RESPeRATE, it has not been cleared by the FDA. To get FDA clearance, extensive clinical studies were performed proving the effectiveness of the RESPeRATE.


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2 People have left comments on this post

Jan 15, 2009 - 12:01:21
Maya said:

Please note that being cleared by the FDA only means that the device has been deemed safe and at least as effective as any similar devices already on the market. More information can be found here: http://www.fda.gov/cdrh/consumer/geninfo.html.

Also, the Zona Plus has been cleared by the FDA (see here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&regnum=77738).

Jan 16, 2009 - 03:01:18
Dr. Rowena said:

It is true that the Zona Plus is registered with the FDA. It is registered as a Class I “powered exercise equipment” exempt from the regulatory process (as are 95% of Class I devices). See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=890.5380

RESPeRATE, on the other hand, is an FDA Class II regulated device. It is the only clinically proven device specifically indicated by the FDA for the adjunctive treatment of hypertension (with other pharmacological and/or non-pharmacological interventions). See FDA certificate and indication: http://www.fda.gov/cdrh/pdf2/k020399.pdf