SmartTENS
FDA 510(k) clearance K143430 · decided 2015-05-29
Clearance details
- K-number
- K143430
- Device name
- SmartTENS
- Applicant
- Easy Med Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-01
- Decision date
- 2015-05-29
- Days to decision
- 179 days
- Clearance type
- Abbreviated
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Daliang, Shunde, Foshan, Guang Dong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.