VEINOPLUS Back
FDA 510(k) clearance K251958 · decided 2025-12-23
Clearance details
- K-number
- K251958
- Device name
- VEINOPLUS Back
- Applicant
- Dynapulse Medical
- Decision
- Substantially Equivalent
- Date received
- 2025-06-25
- Decision date
- 2025-12-23
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.