Home / 510(k) Clearances / K033358

510(k) K033358

CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 by Surgitech, Inc. — Product Code LIH

K033358 is an FDA 510(k) premarket notification submitted by Surgitech, Inc. for the device "CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Surgitech, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
October 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Surgitech, Inc.

  • K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (July 31, 2003)

Other clearances for product code LIH

  • K231575 — Vecttor VT-300 (February 8, 2024)
  • K202725 — ETD4000 (March 26, 2021)
  • K183692 — Avid IF2 (June 12, 2019)
  • K122944 — GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (December 21, 2012)
  • K121662 — VECTTOR VT-200 (November 21, 2012)
  • K110509 — EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 (June 20, 2011)
  • K100246 — MAX-IF1000 (November 24, 2010)
  • K092780 — INF 4160 PLUS, MODEL D-FJ31F (January 7, 2010)
  • K092763 — IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D (October 8, 2009)
  • K090023 — IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E (January 30, 2009)

FDA data resources