The following data is part of a premarket notification filed by Kinsei Shiatsu, Inc. with the FDA for Shiatsu Master Massager Cushion.
| Device ID | K952916 |
| 510k Number | K952916 |
| Device Name: | SHIATSU MASTER MASSAGER CUSHION |
| Classification | Vibrator, Therapeutic |
| Applicant | KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance, CA 90502 |
| Contact | Haru Ishimoto |
| Correspondent | Haru Ishimoto KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance, CA 90502 |
| 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 | 1995-06-26 |
| Decision Date | 1995-08-28 |