The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Choice Powered Wheelchair.
Device ID | K963808 |
510k Number | K963808 |
Device Name: | CHOICE POWERED WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | AMERICAN MEDICAL TECHNOLOGY, INC. 160 LEE ST. Canton, GA 30114 |
Contact | J.r. Mclaughlin |
Correspondent | J.r. Mclaughlin AMERICAN MEDICAL TECHNOLOGY, INC. 160 LEE ST. Canton, GA 30114 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-23 |
Decision Date | 1997-02-12 |
Summary: | summary |