The following data is part of a premarket notification filed by Conair Corp. with the FDA for Health Essentials Maxi Massager.
| Device ID | K924581 |
| 510k Number | K924581 |
| Device Name: | HEALTH ESSENTIALS MAXI MASSAGER |
| Classification | Vibrator, Therapeutic |
| Applicant | CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
| Contact | Jeffery A Word |
| Correspondent | Jeffery 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 |