Identity
- Trade Name
- TENS One EUDAMEDTenscare FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- TENS One EUDAMEDTENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras. FDA UDI
- Model / Reference
- K-TENSONE EUDAMEDTENS One FDA UDI
- Description
- TENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras. FDA UDI
Identifiers
- Catalog Number
- K-TENSONE FDA UDI
- Primary DI / UDI-DI
- 05033435134045 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435E00075XF EUDAMED
- FDA Product Code
- NUH FDA UDI
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Medical Purpose
- TENS One is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. The device is suitable for use by all who can control the device and understand the instructions. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TENS One by TensCare Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5033435E00075XF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (2)
- EUDAMED b2ca35af-d895-4afa-a412-c1426c33293a 61 fields · synced Jul 14, 2026
- FDA UDI 9bea6bcf-26ec-4970-bb20-2c9f1c425652 35 fields · synced May 30, 2026