TENS & PMS (Model: SM9126)
FDA 510(k) clearance K220150 · decided 2022-02-17
Clearance details
- K-number
- K220150
- Device name
- TENS & PMS (Model: SM9126)
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-01-19
- Decision date
- 2022-02-17
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenzhen, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.