Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
FDA 510(k) clearance K223428 · decided 2023-05-08
Clearance details
- K-number
- K223428
- Device name
- Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
- Applicant
- Shenzhen Leqing Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-14
- Decision date
- 2023-05-08
- Days to decision
- 175 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
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.