The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Power Tilt And Recline System.
| Device ID | K010917 |
| 510k Number | K010917 |
| Device Name: | POWER TILT AND RECLINE SYSTEM |
| Classification | Wheelchair, Powered |
| Applicant | SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Contact | John Gerhold |
| Correspondent | John Gerhold SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00016958044256 | K010917 | 000 |