The following data is part of a premarket notification filed by Conair Corp. with the FDA for Arthritic Heat Wrap.
Device ID | K925820 |
510k Number | K925820 |
Device Name: | ARTHRITIC HEAT WRAP |
Classification | Pad, Heating, Powered |
Applicant | CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
Contact | Jaeffrey A Word |
Correspondent | Jaeffrey A Word CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
Product Code | IRT |
CFR Regulation Number | 890.5740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-17 |
Decision Date | 1994-02-02 |