The following data is part of a premarket notification filed by Ultrassage, Inc. with the FDA for Hand Massage Unit.
| Device ID | K950400 |
| 510k Number | K950400 |
| Device Name: | HAND MASSAGE UNIT |
| Classification | Vibrator, Therapeutic |
| Applicant | ULTRASSAGE, INC. 5680 RUE PARE, Ville Mont-royal, Quebec, CA H4p 2m2 |
| Contact | Ken Kupelian |
| Correspondent | Ken Kupelian ULTRASSAGE, INC. 5680 RUE PARE, Ville Mont-royal, Quebec, CA H4p 2m2 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-03-30 |