The following data is part of a premarket notification filed by Kinsei Shiatsu, Inc. with the FDA for Relaxy-the Wonder Hand.
| Device ID | K950322 |
| 510k Number | K950322 |
| Device Name: | RELAXY-THE WONDER HAND |
| Classification | Massager, Therapeutic, Electric |
| Applicant | KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance, CA 90502 |
| Contact | Koji Nishida |
| Correspondent | Koji Nishida KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance, CA 90502 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-26 |
| Decision Date | 1995-02-14 |