TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
FDA 510(k) clearance K230443 · decided 2023-05-22
Clearance details
- K-number
- K230443
- Device name
- TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
- Applicant
- Jiangxi Royall Smart Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-21
- Decision date
- 2023-05-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ganzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.