Identity
- Trade Name
- Johari Digital Healthcare Ltd. FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- "MyoBody XT is a sleek, multifunctional colored touch screen LCD desktop device. The device provides electrical muscle stimulation, interferential muscle stimulation, premod stimulation through four outputs. User can easily select any of the modes by one touch through the colored touch screen LCD display which displays selectable treatments, outputs, treatment time and intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. " FDA UDI
- Model / Reference
- MyoBody XT FDA UDI
- Description
- "MyoBody XT is a sleek, multifunctional colored touch screen LCD desktop device. The device provides electrical muscle stimulation, interferential muscle stimulation, premod stimulation through four outputs. User can easily select any of the modes by one touch through the colored touch screen LCD display which displays selectable treatments, outputs, treatment time and intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908008085475 FDA UDI
- 510(k) Number
- K131291 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
No
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
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 97fdef2c-9d61-4831-ae80-415280b2b4a4 34 fields · synced May 31, 2026