The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Shoprider - Te889.
Device ID | K920654 |
510k Number | K920654 |
Device Name: | SHOPRIDER - TE889 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | PRIDE HEALTH CARE, INC. 71 S. MAIN ST. Pittston, PA 18640 |
Contact | Thomas Kretchik |
Correspondent | Thomas Kretchik PRIDE HEALTH CARE, INC. 71 S. MAIN ST. Pittston, PA 18640 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-12 |
Decision Date | 1992-03-12 |