The following data is part of a premarket notification filed by General Components Intl., Inc. with the FDA for Zero Gravity Wheelchair.
Device ID | K931751 |
510k Number | K931751 |
Device Name: | ZERO GRAVITY WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | GENERAL COMPONENTS INTL., INC. 363 W. 2720 SOUTH, SUITE B Salt Lake City, UT 84115 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-08 |
Decision Date | 1993-07-22 |