FDA UDI
In Commercial Distribution
🇺🇸 United States
Johari Digital Healthcare Ltd.
DI: 08908008085376
·
Model: Myolift 600
·
JOHARI DIGITAL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Johari Digital Healthcare Ltd.
- Primary DI
- 08908008085376
- Version / Model
- Myolift 600
- Company Name
- JOHARI DIGITAL HEALTHCARE LIMITED
- Labeler DUNS
- 675938472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 3
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 25525fdc-dd0f-4b4f-9c68-f3cfc8a8dd2d
Device Description
600 is the latest True Microcurrent machine designed for professional use. Delivering true intensity ranging from 175 to 600 micro amps, this machine ignites the ATP stimulation and sets a standard for non-invasive technology and the ability to provide long-lasting, natural facial lifting and toning results. This powerful True Microcurrent machine is only for licensed cosmetologists, aesthetics, or acupuncturists. This microcurrent machine for professionals is a perfect tool for boosting ATP for anti-aging, cellular repair, muscle re-education, skin firmness and tightening.
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
- Yes
- 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 |
|---|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Neurology | 882.5890 | 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 | 08908008085376 | GS1 |
Customer Contacts
- Phone
- 982-805-4228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112351 | 000 |