The following data is part of a premarket notification filed by C.t.m. Homecare Product, Inc. with the FDA for C.t.m. Mobilitty Scooter # Hs-295.
Device ID | K070603 |
510k Number | K070603 |
Device Name: | C.T.M. MOBILITTY SCOOTER # HS-295 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | C.T.M. HOMECARE PRODUCT, INC. 29611 SIMMONS ROAD Eugene, OR 97405 |
Contact | Linda J Bovard |
Correspondent | Linda J Bovard C.T.M. HOMECARE PRODUCT, INC. 29611 SIMMONS ROAD Eugene, OR 97405 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-05 |
Decision Date | 2007-03-20 |
Summary: | summary |