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510(k) K100246

MAX-IF1000 by Bio Protech, Inc. — Product Code LIH

K100246 is an FDA 510(k) premarket notification submitted by Bio Protech, Inc. for the device "MAX-IF1000". The FDA issued a decision of Substantially Equivalent on November 24, 2010. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Bio Protech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2010
Date Received
January 27, 2010
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 Bio Protech, Inc.

  • K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (March 21, 2016)
  • K143103 — PROPENCIL Smoke Pencil (July 16, 2015)
  • K142099 — CUTANEOUS ELECTRODES (November 17, 2014)
  • K111270 — REUSABLE STIMULATING ELECTRODES (September 13, 2011)
  • K091248 — MAXEMS, MODELS 1000 AND 2000 (November 30, 2009)
  • K092732 — PROPENCIL ESU PENCIL (November 25, 2009)
  • K092761 — PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (November 24, 2009)
  • K083148 — TELECTRODE WET GEL ECG ELECTRODE (November 7, 2008)

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)
  • 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