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510(k) K161453

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A by Well-Life Healthcare Limited — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2016
Date Received
May 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Well-Life Healthcare Limited

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  • 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)
  • K162663 — WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A an (January 17, 2017)
  • 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 NUH

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  • K251958 — VEINOPLUS Back (December 23, 2025)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (November 24, 2025)
  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K243131 — Triathlon Pro (November 7, 2025)
  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)