The following data is part of a premarket notification filed by Windmere Corp. with the FDA for Windmere Vibra Touch Personal Body Massager.
| Device ID | K931086 |
| 510k Number | K931086 |
| Device Name: | WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER |
| 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 | 1993-03-03 |
| Decision Date | 1993-09-30 |