OTC Combo TENS/EMS System
FDA 510(k) clearance K172809 · decided 2017-10-18
Clearance details
- K-number
- K172809
- Device name
- OTC Combo TENS/EMS System
- Applicant
- Well-Life Healthcare Limited
- Decision
- Substantially Equivalent
- Date received
- 2017-09-18
- Decision date
- 2017-10-18
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Yunghe Dist, New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.