The following data is part of a premarket notification filed by Warepalmy Enterprise Llc (usa) with the FDA for C.t.m. Mobility Scooter Model # Hs-320.
| Device ID | K012791 |
| 510k Number | K012791 |
| Device Name: | C.T.M. MOBILITY SCOOTER MODEL # HS-320 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | WAREPALMY ENTERPRISE LLC (USA) 3636 EAST COLUMBINE DR. Phoenix, AZ 85032 -7372 |
| Contact | Robert S Mcquate |
| Correspondent | Robert S Mcquate WAREPALMY ENTERPRISE LLC (USA) 3636 EAST COLUMBINE DR. Phoenix, AZ 85032 -7372 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-20 |
| Decision Date | 2001-10-24 |
| Summary: | summary |