WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A— 510(k) K161453
Substantially EquivalentWell-Life Healthcare Limited
FDA 510(k) clearance K161453 for WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A, Substantially Equivalent on 2016-12-05. Applicant: Well-Life Healthcare Limited. Device class: 2.
Clearance details
- Applicant
- Well-Life Healthcare Limited
- Product code
- Product code NUH
- 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.