The following data is part of a premarket notification filed by Surgitech, Inc. with the FDA for Chronic Pain Suppressor Cps-2000, Model Cps-2000.
Device ID | K033358 |
510k Number | K033358 |
Device Name: | CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 |
Classification | Interferential Current Therapy |
Applicant | SURGITECH, INC. 2424 VISTA WAY, SUITE 300 Oceanside, CA 92054 |
Contact | Christopher Crowell |
Correspondent | Christopher Crowell SURGITECH, INC. 2424 VISTA WAY, SUITE 300 Oceanside, CA 92054 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-20 |
Decision Date | 2003-11-14 |
Summary: | summary |