Identity
- Trade Name
- Johari Digital Healthcare Ltd. FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- truFlex comprises a system console with a touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses to the skin in direct proximity to the muscles to be stimulated. The electrical impulses are delivered in the subdermal muscular tissue area, triggering comforting and soothing muscle stimulation to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. FDA UDI
- Model / Reference
- truSculpt Flex FDA UDI
- Description
- truFlex comprises a system console with a touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses to the skin in direct proximity to the muscles to be stimulated. The electrical impulses are delivered in the subdermal muscular tissue area, triggering comforting and soothing muscle stimulation to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908008085345 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Johari Digital Healthcare Ltd. by Syrma Johari Medtech Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131291 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Syrma Johari Medtech Limited
Sources (1)
- FDA UDI 1e8dcd81-37fd-4f56-aef9-5e5b050477cf 35 fields · synced May 30, 2026