FDA UDI
In Commercial Distribution
🇺🇸 United States
Transcutaneous Electrical Nerve Stimulators
DI: 06924607702256
·
Model: KTR-2211
·
Shenzhen Kentro Medical Electronics Co.,Ltd
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Transcutaneous Electrical Nerve Stimulators
- Primary DI
- 06924607702256
- Version / Model
- KTR-2211
- Company Name
- Shenzhen Kentro Medical Electronics Co.,Ltd
- Labeler DUNS
- 544395368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-09
- Public Version
- 1
- Public Version Date
- 2021-12-17
- Public Version Status
- New
- Public Device Record Key
- 6588e123-d23c-415b-931e-7250fc7c6e37
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06924607702256 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191982 | 000 |