Identity
- Trade Name
- Sports TENS 2 EUDAMEDTensCare FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Sports TENS 2 EUDAMEDSports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Sports TENS 2 is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has fifty preset treatment programs and four manually adjustable programmes are available. FDA UDI
- Model / Reference
- K-ST2 EUDAMEDSports TENS 2 FDA UDI
- Description
- Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Sports TENS 2 is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has fifty preset treatment programs and four manually adjustable programmes are available. FDA UDI
Identifiers
- Catalog Number
- K-ST2 FDA UDI
- Primary DI / UDI-DI
- 05033435120239 EUDAMEDFDA UDI05033435136346 EUDAMED
- Basic UDI-DI
- 5033435K00065ZS EUDAMED5033435K00065DST EUDAMED
- 510(k) Number
- K200694 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Market of Registration
- Poland EUDAMED
- Medical Purpose
- Sports TENS 2 is a medical device designed to be used in the home healthcare environment to improve muscle tone and bulk, as well as provide symptomatic relief and management of acute or chronic localised pain and muscle pain. It 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
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sports TENS 2 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 | 5033435K00065ZS | 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 (3)
- EUDAMED b0132575-4324-4559-8dc4-e51f5b3c6e94 61 fields · synced Jul 10, 2026
- EUDAMED 4a3b9639-548b-438b-8a13-01b14ae4fe2f 61 fields · synced May 17, 2026
- FDA UDI c5725cde-1b6a-4ba2-9109-1f710cf5238a 35 fields · synced May 30, 2026