The following data is part of a premarket notification filed by Accelerated Rehab Designs, Inc. with the FDA for E-2000 Power Elevating Seat System, Models Ard-estorm, Ard-ep320, Ard-elancer.
Device ID | K992828 |
510k Number | K992828 |
Device Name: | E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER |
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 | 1999-08-23 |
Decision Date | 2000-02-03 |
Summary: | summary |