Johari Digital Healthcare Ltd.
Basic Information
- Brand Name
- Johari Digital Healthcare Ltd.
- Primary DI
- 08908008085475
- Version / Model
- MyoBody XT
- Company Name
- SYRMA JOHARI MEDTECH LIMITED
- Labeler DUNS
- 675938472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-04
- Public Version
- 2
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- 97fdef2c-9d61-4831-ae80-415280b2b4a4
Device 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. "
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08908008085475 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131291 | 000 |