The following data is part of a premarket notification filed by Conair Corp. with the FDA for Health Essentials Multi-purpose Massager.
Device ID | K924583 |
510k Number | K924583 |
Device Name: | HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER |
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 | 1992-09-10 |
Decision Date | 1993-10-12 |