The following data is part of a premarket notification filed by Warepalmy Enterprise Llc (usa) with the FDA for C.t.m. Power Chair, Model Hs-5600.
| Device ID | K002983 |
| 510k Number | K002983 |
| Device Name: | C.T.M. POWER CHAIR, MODEL HS-5600 |
| Classification | Wheelchair, Powered |
| 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 | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852202007444 | K002983 | 000 |
| 00850017490451 | K002983 | 000 |