18-01-2011, 12:14
Brava is NOT FDA approved! Dont kid yourself!
July 30 2007 at 8:15 AM Lost Sheep (no login)
--------------------------------------------------------------------------------
I read on a few different websites now that Brava claims it's FDA approved...HOWEVER...it is only approved as an unregulated device. Meaning, it could be extremely unsafe or it could be fine for women...but...the FDA has not approved it as being a safe device. Just thought everyone should know.
"Q: Is the product FDA approved?
A: No. According to the Berkeley Wellness Letter, "the FDA has not reviewed it for effectiveness, but allowed it on the market as an unregulated device."
So for those of you who won't go ahead and try the 'better than brava' machine, now you can see there is no reason to hold yourself back. I've read so many women saying "Well, is the better than brava machine FDA approved?" Answer is no. But neither is Brava.
Author Reply
Natasha
(no login) Re: Brava is NOT FDA approved! Dont kid yourself! July 30 2007, 8:47 AM
Brava have been making this claim for a long time. The fact is that the FDA decided that this kind of device isn't something that requires FDA approval as it doesn't fall within any of their regulations.
Lost Sheep
(no login) Re: Brava is NOT FDA approved! Dont kid yourself! July 30 2007, 6:51 PM
Okay, well in that case, the 'better than brava' machine falls under the exact same category and also doesnt need to be regulated. Good news!
July 30 2007 at 8:15 AM Lost Sheep (no login)
--------------------------------------------------------------------------------
I read on a few different websites now that Brava claims it's FDA approved...HOWEVER...it is only approved as an unregulated device. Meaning, it could be extremely unsafe or it could be fine for women...but...the FDA has not approved it as being a safe device. Just thought everyone should know.
"Q: Is the product FDA approved?
A: No. According to the Berkeley Wellness Letter, "the FDA has not reviewed it for effectiveness, but allowed it on the market as an unregulated device."
So for those of you who won't go ahead and try the 'better than brava' machine, now you can see there is no reason to hold yourself back. I've read so many women saying "Well, is the better than brava machine FDA approved?" Answer is no. But neither is Brava.
Author Reply
Natasha
(no login) Re: Brava is NOT FDA approved! Dont kid yourself! July 30 2007, 8:47 AM
Brava have been making this claim for a long time. The fact is that the FDA decided that this kind of device isn't something that requires FDA approval as it doesn't fall within any of their regulations.
Lost Sheep
(no login) Re: Brava is NOT FDA approved! Dont kid yourself! July 30 2007, 6:51 PM
Okay, well in that case, the 'better than brava' machine falls under the exact same category and also doesnt need to be regulated. Good news!