WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A— 510(k) K162663
Substantially EquivalentWell-Life Healthcare Limited
FDA 510(k) clearance K162663 for WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A, Substantially Equivalent on 2017-01-17. Applicant: Well-Life Healthcare Limited. Device class: 2.
Clearance details
- Applicant
- Well-Life Healthcare Limited
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yunghe Dist, New Taipei City, TW
Recent devices under product code GZJ
view allMore clearances from Well-Life Healthcare Limited
view all- K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator +3 more
- K222528 — Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
- K220524 — Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
- K213091 — Well-Life TENS/EMS/Heating Stimulator
- K200942 — Well-Life Garment Electrodes (GM Series)
Data sourced from openFDA. This site is unofficial and independent of the FDA.