The following data is part of a premarket notification filed by Conair Corp. with the FDA for Body Flex.
Device ID | K942950 |
510k Number | K942950 |
Device Name: | BODY FLEX |
Classification | Massager, Therapeutic, Electric |
Applicant | CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
Contact | Jeffrey A Word |
Correspondent | Jeffrey A Word CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-23 |
Decision Date | 1994-07-26 |