The following data is part of a premarket notification filed by Conair Corp. with the FDA for Bodytherm.
| Device ID | K924519 |
| 510k Number | K924519 |
| Device Name: | BODYTHERM |
| Classification | Vibrator, Therapeutic |
| 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 | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1993-10-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BODYTHERM 74656458 not registered Dead/Abandoned |
ThermaLink Corporation, Inc. 1995-04-05 |
![]() BODYTHERM 74185862 1746367 Dead/Cancelled |
Conair Corporation 1991-07-17 |