The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Jazzy Frontie.
Device ID | K092961 |
510k Number | K092961 |
Device Name: | JAZZY FRONTIE |
Classification | Wheelchair, Powered |
Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Contact | Kimberly Blake |
Correspondent | Kimberly Blake PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-25 |
Decision Date | 2009-10-23 |
Summary: | summary |