EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only— 510(k) K163166
Substantially EquivalentEasywell Biomedicals, Inc.
FDA 510(k) clearance K163166 for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only, Substantially Equivalent on 2017-08-11. Applicant: Easywell Biomedicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Easywell Biomedicals, Inc.
- Product code
- 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
- Hsinchu, TW
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