The following data is part of a premarket notification filed by Everapex Design & Marketing Corp. with the FDA for Comfort, Muscle, Cordless Massager, Battery Powered Operated Massager.
| Device ID | K955160 |
| 510k Number | K955160 |
| Device Name: | COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER |
| Classification | Vibrator, Therapeutic |
| Applicant | EVERAPEX DESIGN & MARKETING CORP. 4TH FL., NO. 272, SEC. 4, CHENG-TEH ROAD Taipei, TW |
| Contact | Peter Liao |
| Correspondent | Peter Liao EVERAPEX DESIGN & MARKETING CORP. 4TH FL., NO. 272, SEC. 4, CHENG-TEH ROAD Taipei, TW |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-02-08 |