FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VEINOPLUS Back
K Number: K251958
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
1
Review Days
181
Basic Information
- Device Name
- VEINOPLUS Back
- K Number
- K251958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dynapulse Medical
- Date Received
- June 25, 2025
- Decision Date
- December 23, 2025
- Product Code
- NUH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
FDA 510(k)
FDA Class 2
·Neurology
TENS/EMS device (GUSE01)
FDA 510(k)
FDA Class 2
·Neurology
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
FDA 510(k)
FDA Class 2
·Neurology
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
FDA 510(k)
FDA Class 2
·Neurology
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
FDA 510(k)
FDA Class 2
·Neurology
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
FDA 510(k)
FDA Class 2
·Neurology