FDA UDI
In Commercial Distribution
🇺🇸 United States
Z TEK
DI: 00860000205191
·
Model: F7
·
Z TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Z TEK
- Primary DI
- 00860000205191
- Version / Model
- F7
- Catalog Number
- N/A
- Company Name
- Z TECHNOLOGIES LLC
- Labeler DUNS
- 799545652
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-22
- Public Version
- 6
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- ea64f621-e173-442b-996e-97cad9703e9e
Device Description
TENS DEVICE The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 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 | 00860000205191 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K965244 | 000 |