The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Victory Three Wheel Scooter, Model: Sc610.
Device ID | K072165 |
510k Number | K072165 |
Device Name: | VICTORY THREE WHEEL SCOOTER, MODEL: SC610 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Contact | Thomas J Schappert |
Correspondent | Thomas J Schappert PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-06 |
Decision Date | 2007-08-17 |
Summary: | summary |