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510(k) K082011

MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 by Bio-Medical Research, Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2008
Date Received
July 15, 2008
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)
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  • K112934 — NEUROTECH RECOVERY (January 20, 2012)
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  • K102614 — AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 (June 3, 2011)

Other clearances for product code GZJ

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  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • 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)