The following data is part of a premarket notification filed by Premier Designs with the FDA for E Z Chair.
Device ID | K993298 |
510k Number | K993298 |
Device Name: | E Z CHAIR |
Classification | Wheelchair, Mechanical |
Applicant | PREMIER DESIGNS 4834 W. JACQUELYN, SUITE 101 Fresno, CA 93722 |
Contact | Chris Berryhill |
Correspondent | Chris Berryhill PREMIER DESIGNS 4834 W. JACQUELYN, SUITE 101 Fresno, CA 93722 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-01 |
Decision Date | 1999-11-16 |