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510(k) K161091

STIMPOD NMS460 Nerve Stimulator by Xavant Technology (Pty), Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2017
Date Received
April 18, 2016
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

Other clearances by Xavant Technology (Pty), Ltd.

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • K140853 — STIMPOD ST2-3010 NERVE STIMULATOR (November 6, 2014)
  • K110118 — STIMTRODE SINGLE USE NERVE STIMULATOR (February 17, 2011)
  • K102084 — STIMPOD NMS450 NERVE STIMULATOR (December 16, 2010)
  • K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR (December 3, 2009)
  • K072092 — XPOD/XMAP NERVE STIMULATOR (November 15, 2007)

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)