The following data is part of a premarket notification filed by Accelerated Rehab Designs, Inc. with the FDA for Trs-2000 Power Tilt/power Recline System.
| Device ID | K012281 |
| 510k Number | K012281 |
| Device Name: | TRS-2000 POWER TILT/POWER RECLINE SYSTEM |
| Classification | Wheelchair, Powered |
| Applicant | ACCELERATED REHAB DESIGNS, INC. 32025 INDUSTRIAL PARK DR. Pinehurst, TX 77362 |
| Contact | Randall Potter |
| Correspondent | Randall Potter ACCELERATED REHAB DESIGNS, INC. 32025 INDUSTRIAL PARK DR. Pinehurst, TX 77362 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-20 |
| Decision Date | 2001-08-01 |
| Summary: | summary |