The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Riser Standup Wheelchair.
Device ID | K832696 |
510k Number | K832696 |
Device Name: | RISER STANDUP WHEELCHAIR |
Classification | Wheelchair, Standup |
Applicant | IMEX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-10 |
Decision Date | 1983-09-20 |