The following data is part of a premarket notification filed by First World Services, Inc. with the FDA for Mechanical Daily Use Wheelchair.
Device ID | K021075 |
510k Number | K021075 |
Device Name: | MECHANICAL DAILY USE WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | FIRST WORLD SERVICES, INC. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
Contact | Leonard Frier |
Correspondent | Leonard Frier FIRST WORLD SERVICES, INC. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-02 |
Decision Date | 2002-07-12 |