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510(k) K102786

WELL-LIFE OTC EMS SYSTEM by Well-Life Healthcare Limited — Product Code NGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2011
Date Received
September 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Other clearances by Well-Life Healthcare Limited

  • K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Mens (October 18, 2024)
  • 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)
  • K162663 — WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A an (January 17, 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)

Other clearances for product code NGX

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  • K253408 — CoolTone (January 16, 2026)
  • K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-232 (December 9, 2025)
  • K253478 — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (November 6, 2025)
  • K251594 — truFlex (August 28, 2025)
  • K251706 — TENS and EMS Unit (July 30, 2025)
  • K251378 — CoolTone (July 14, 2025)
  • K251746 — Pure Impact (July 2, 2025)
  • K250759 — 3 in 1 TENS UNIT (June 13, 2025)
  • K242926 — XBody Go USA, XBody Pro USA (May 30, 2025)