FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Triathlon Pro
K Number: K243131
·
Decision Nov 7, 2025
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
1
Review Days
403
Basic Information
- Device Name
- Triathlon Pro
- K Number
- K243131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sigma Biomedical
- Date Received
- September 30, 2024
- Decision Date
- November 7, 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 |
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