The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Tmr48.
| Device ID | K953342 |
| 510k Number | K953342 |
| Device Name: | TMR48 |
| Classification | Chair, Positioning, Electric |
| Applicant | PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644 |
| Contact | George Amadei |
| Correspondent | George Amadei PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644 |
| Product Code | INO |
| CFR Regulation Number | 890.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-11 |
| Decision Date | 1995-09-08 |