The following data is part of a premarket notification filed by Ergo-air, Inc. with the FDA for Ergomat 5000 System.
| Device ID | K952093 |
| 510k Number | K952093 |
| Device Name: | ERGOMAT 5000 SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | ERGO-AIR, INC. 30 HOOPER ST. Westbury, NY 11590 |
| Contact | Peter W Linley |
| Correspondent | Peter W Linley ERGO-AIR, INC. 30 HOOPER ST. Westbury, NY 11590 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-03 |
| Decision Date | 1995-07-26 |