The following data is part of a premarket notification filed by Intl. Medical Equipment Corp. with the FDA for Base Only, Power Wheelchair.
Device ID | K832325 |
510k Number | K832325 |
Device Name: | BASE ONLY, POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | INTL. MEDICAL EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-15 |
Decision Date | 1983-08-12 |