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 118.
| Device ID | K110395 |
| 510k Number | K110395 |
| Device Name: | C.T.M. MOBILITY SCOOTER - MODEL HS 118 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | C.T.M. HOMECARE PRODUCT, INC. 927 THRONE DRIVE Eugene, OR 97402 |
| Contact | Sheila Ramerman |
| Correspondent | Sheila Ramerman C.T.M. HOMECARE PRODUCT, INC. 927 THRONE DRIVE Eugene, OR 97402 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-04-22 |
| Summary: | summary |