The following data is part of a premarket notification filed by Brownstone Trading Co. with the FDA for Folding, Wheelchair.
Device ID | K925146 |
510k Number | K925146 |
Device Name: | FOLDING, WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | BROWNSTONE TRADING CO. 714 EAST UNIVERSITY El Paso, TX 79902 |
Contact | Pat O'rourke |
Correspondent | Pat O'rourke BROWNSTONE TRADING CO. 714 EAST UNIVERSITY El Paso, TX 79902 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-13 |
Decision Date | 1993-02-12 |