The following data is part of a premarket notification filed by Windmere Corp. with the FDA for Sound Relief.
| Device ID | K912659 |
| 510k Number | K912659 |
| Device Name: | SOUND RELIEF |
| Classification | Vibrator, Therapeutic |
| Applicant | WINDMERE CORP. 5980 MIAMI LADES DR. Miami Lakes, FL 33014 |
| Contact | Dee Eichenberger |
| Correspondent | Dee Eichenberger WINDMERE CORP. 5980 MIAMI LADES DR. Miami Lakes, FL 33014 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1991-09-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOUND RELIEF 86424279 4759428 Live/Registered |
The Sound Relief Center, LLC 2014-10-15 |
![]() SOUND RELIEF 74139695 1779591 Dead/Cancelled |
WINDMERE CORPORATION 1991-02-15 |