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510(k) K110350

KNEEHAB XP by Bio-Medical Research, Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2011
Date Received
February 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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  • K161974 — SLENDERTONE® Connect Abs, Type 570 (November 1, 2016)
  • K151903 — Slendertone connect Abs (November 6, 2015)
  • K112934 — NEUROTECH RECOVERY (January 20, 2012)
  • K112258 — NEUROTECH PLUS (January 9, 2012)
  • K103031 — BMR FACE (November 10, 2011)
  • K102614 — AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 (June 3, 2011)
  • K100556 — SLENDERTONE FLEX MAX, MODEL 517 US (August 2, 2010)

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  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)