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510(k) K162663

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A by Well-Life Healthcare Limited — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2017
Date Received
September 26, 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 Well-Life Healthcare Limited

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  • K222528 — Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incon (December 29, 2022)
  • K220524 — Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) (August 4, 2022)
  • K213091 — Well-Life TENS/EMS/Heating Stimulator (February 19, 2022)
  • K200942 — Well-Life Garment Electrodes (GM Series) (June 1, 2021)
  • K172809 — OTC Combo TENS/EMS System (October 18, 2017)
  • K161453 — WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A (December 5, 2016)
  • K141299 — OTC COMBO TENS/EMS SYSTEM (November 14, 2014)
  • K133723 — OTC PATCH (January 28, 2014)
  • K123075 — BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413 (July 11, 2013)

Other clearances for product code GZJ

  • K252767 — actiTENS mini (January 16, 2026)
  • K252236 — CP Relief Wand Rx - TENS/NMES (August 15, 2025)
  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • 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)