FDA 510(k)
FDA class 1
Substantially Equivalent
🇪🇸 Spain
VMAT PRO
K Number: K243488
·
Decision Feb 6, 2025
Classifications
1
FEI Numbers
783
Registration Numbers
783
Same Product Code
99
Applicant Total
5
Review Days
86
Basic Information
- Device Name
- VMAT PRO
- K Number
- K243488
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TermoSalud
- Date Received
- November 12, 2024
- Decision Date
- February 6, 2025
- Product Code
- ISA
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
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