The following data is part of a premarket notification filed by Contemporary Health Sys with the FDA for Qualine Wheelchair Products.
Device ID | K843213 |
510k Number | K843213 |
Device Name: | QUALINE WHEELCHAIR PRODUCTS |
Classification | Wheelchair, Special Grade |
Applicant | CONTEMPORARY HEALTH SYS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IQC |
CFR Regulation Number | 890.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-15 |
Decision Date | 1984-08-24 |