The following data is part of a premarket notification filed by Reif Wheelchairs And Accessories, Inc. with the FDA for The Reiff Quantum Wheelchair, Or Quantum Wheelchairs.
Device ID | K954568 |
510k Number | K954568 |
Device Name: | THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS |
Classification | Wheelchair, Mechanical |
Applicant | REIF WHEELCHAIRS AND ACCESSORIES, INC. 0510 NORTH 1000 EAST Lagrange, IN 46761 |
Contact | Richard E Reiff |
Correspondent | Richard E Reiff REIF WHEELCHAIRS AND ACCESSORIES, INC. 0510 NORTH 1000 EAST Lagrange, IN 46761 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-02 |
Decision Date | 1995-10-31 |