The following data is part of a premarket notification filed by Accelerated Rehab Designs, Inc. with the FDA for T-2000-power Tilt Seating System, Models Ard-tstorm, Ard-tp-320, Ard-tg424, Ard-ts525, Ard-tjazzy, Ard-tlancer.
Device ID | K992804 |
510k Number | K992804 |
Device Name: | T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER |
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 | 1999-08-19 |
Decision Date | 2000-02-03 |
Summary: | summary |