The following data is part of a premarket notification filed by Ergo-air, Inc. with the FDA for Ergoseat System.
| Device ID | K954162 |
| 510k Number | K954162 |
| Device Name: | ERGOSEAT SYSTEM |
| Classification | Cushion, Flotation, Therapeutic |
| Applicant | ERGO-AIR, INC. 24 WATSON ST. Marblehead, MA 01945 |
| Contact | Margaret N Wainwright |
| Correspondent | Margaret N Wainwright ERGO-AIR, INC. 24 WATSON ST. Marblehead, MA 01945 |
| Product Code | MOC |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-10-30 |