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 |