The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Quantum Blast.
Device ID | K011993 |
510k Number | K011993 |
Device Name: | QUANTUM BLAST |
Classification | Wheelchair, Powered |
Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Contact | Gene R Kulon |
Correspondent | Gene R Kulon 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 | 2001-06-26 |
Decision Date | 2001-07-13 |
Summary: | summary |