The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Jet 1 Powered Wheelchair.
Device ID | K001970 |
510k Number | K001970 |
Device Name: | JET 1 POWERED WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Contact | Gene Kulon |
Correspondent | Gene Kulon PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-28 |
Decision Date | 2000-09-26 |