The following data is part of a premarket notification filed by Pride Mobility Product Corporation with the FDA for Q6 Edge Em.
Device ID | K143383 |
510k Number | K143383 |
Device Name: | Q6 Edge EM |
Classification | Wheelchair, Powered |
Applicant | Pride Mobility Product Corporation 182 Susquehanna Avenue Exeter, PA 18643 |
Contact | Kimberly Elmes |
Correspondent | Kimberly Elmes Pride Mobility Product Corporation 182 Susquehanna Avenue 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 | 2014-11-25 |
Decision Date | 2015-07-23 |
Summary: | summary |