Identity
- Trade Name
- Johari Digital Healthcare Ltd. FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- "This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model is lightweight, small in size, and is battery powered Precise treatment for pain relief Relaxation of muscle spasm Prevention of redardation of disuse atrophy Increase local blood circulation muscle re-education maintaining or increasing range of motion prevent venous thrombosis after surgery. Key Feature: • Channel : Four(941) Electrotherapy • 1 & 3 MHz Ultrasound Applicator • Large Color Touch Screen Display • Pre-programmed Protocols • Inbuilt Rechargeable Battery Pack" FDA UDI
- Model / Reference
- Sonicaor Plus 941 FDA UDI
- Description
- "This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model is lightweight, small in size, and is battery powered Precise treatment for pain relief Relaxation of muscle spasm Prevention of redardation of disuse atrophy Increase local blood circulation muscle re-education maintaining or increasing range of motion prevent venous thrombosis after surgery. Key Feature: • Channel : Four(941) Electrotherapy • 1 & 3 MHz Ultrasound Applicator • Large Color Touch Screen Display • Pre-programmed Protocols • Inbuilt Rechargeable Battery Pack" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908008085420 FDA UDI
- FDA Product Code
- IMG FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5860 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
Similar devices
Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
- COMPEX — DJO, LLC · Class II
- RS-4s Muscle Stimulator System (R) — Rs Medical · Class II
- BodyMed — BOXOUT, LLC · Class II
- veicomtech — Guangzhou Huakai Electronic Technology Co., Ltd. · Class II
- Therapist’s Choice® TENS2N1 Combo — CLINICAL HEALTH SERVICES, INC. · Class II
- iSelfCare — HEALTHMATE INTERNATIONAL, LLC · Class II
- JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Syrma Johari Medtech Limited
Sources (1)
- FDA UDI c4cb5679-1dc3-4781-9e8c-99336bc1ba54 34 fields · synced May 31, 2026