The following data is part of a premarket notification filed by C.t.m. Homecare Product, Inc. with the FDA for C.t.m. Power Chair, Model Hs-2800.
Device ID | K021617 |
510k Number | K021617 |
Device Name: | C.T.M. POWER CHAIR, MODEL HS-2800 |
Classification | Wheelchair, Powered |
Applicant | C.T.M. HOMECARE PRODUCT, INC. 3636 E. COLUMBINE DR. Phoenix, AZ 85032 |
Contact | Robert S Mcquate |
Correspondent | Robert S Mcquate C.T.M. HOMECARE PRODUCT, INC. 3636 E. COLUMBINE DR. Phoenix, AZ 85032 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-16 |
Decision Date | 2002-08-02 |
Summary: | summary |