FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
truFlex
K Number: K251594
·
Decision Aug 28, 2025
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
1
Review Days
93
Basic Information
- Device Name
- truFlex
- K Number
- K251594
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syrma Johari Medtech Limited
- Date Received
- May 27, 2025
- Decision Date
- August 28, 2025
- Product Code
- NGX
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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