The following data is part of a premarket notification filed by C.t.m. Homecare Product, Inc. with the FDA for C.t.m. Mobility Scooter, Model Hs-628, Invacare Orion.
| Device ID | K091418 |
| 510k Number | K091418 |
| Device Name: | C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | C.T.M. HOMECARE PRODUCT, INC. 29611 SIMMONS ROAD Eugene, OR 97405 |
| Contact | Linda Bovard |
| Correspondent | Linda 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 | 2009-05-13 |
| Decision Date | 2009-07-06 |
| Summary: | summary |