The following data is part of a premarket notification filed by Karman Healthcare, Inc. with the FDA for Karman Wheelchair.
Device ID | K002167 |
510k Number | K002167 |
Device Name: | KARMAN WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | KARMAN HEALTHCARE, INC. 137 8TH AVE., #F La Puente, CA 91746 |
Contact | Alex C Horng |
Correspondent | Alex C Horng KARMAN HEALTHCARE, INC. 137 8TH AVE., #F La Puente, CA 91746 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-18 |
Decision Date | 2000-08-25 |