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510(k) K060975

IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 by Theratech, Inc. — Product Code LIH

K060975 is an FDA 510(k) premarket notification submitted by Theratech, Inc. for the device "IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2". The FDA issued a decision of Substantially Equivalent on May 10, 2006. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Theratech, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
April 10, 2006
Clearance Type
Special
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 Theratech, Inc.

  • K050847 — IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A (June 17, 2005)
  • K024100 — IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF A (February 25, 2003)
  • K021436 — TTECH MODEL 200E + TENS DEVICE (July 30, 2002)
  • K013768 — POWERED MUSCLE STIMULATOR (July 3, 2002)

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