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510(k) K202725

ETD4000 by Therasigma, LLC — Product Code LIH

K202725 is an FDA 510(k) premarket notification submitted by Therasigma, LLC for the device "ETD4000". The FDA issued a decision of Substantially Equivalent on March 26, 2021. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Therasigma, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
September 17, 2020
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 Therasigma, LLC

  • K201958 — ETD Family of Electrotherapy Devices (August 4, 2020)

Other clearances for product code LIH

  • K231575 — Vecttor VT-300 (February 8, 2024)
  • 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)
  • K070890 — EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (June 29, 2007)

FDA data resources