The following data is part of a premarket notification filed by International Healthcare Solutions, Inc. with the FDA for Chips Standup Wheelchair.
Device ID | K955547 |
510k Number | K955547 |
Device Name: | CHIPS STANDUP WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | INTERNATIONAL HEALTHCARE SOLUTIONS, INC. 368 W. VETERANS HIGHWAY Commack, NY 11725 |
Contact | Fred Di Vito |
Correspondent | Fred Di Vito INTERNATIONAL HEALTHCARE SOLUTIONS, INC. 368 W. VETERANS HIGHWAY Commack, NY 11725 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-05 |
Decision Date | 1996-09-20 |
Summary: | summary |