Home / 510(k) Clearances / K082065

510(k) K082065

WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP by Well-Life Healthcare Limited — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2009
Date Received
July 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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 GXY

  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)
  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)