The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Kids Rock 3 Chair.
Device ID | K111739 |
510k Number | K111739 |
Device Name: | KIDS ROCK 3 CHAIR |
Classification | Wheelchair, Mechanical |
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 | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-21 |
Decision Date | 2011-08-12 |
Summary: | summary |