← Back to catalogue

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231425Ref neurotech PolyStim XP+Model TENS Eco 2, TENS Eco, URO stim2, TENStem eco basic, TENS WMPS2-1,neurotech OmniTens XP+, neurotech PolyStim XP+, neurotech AvivaTens PlusRef TENStem eco basicRef URO stim2

by Wuxi Jiajian Medical Instrument Co., Ltd.

Identity

Trade Name
Transcutaneous Electrical Nerve Stimulator EUDAMED
Device Name
Transcutaneous Electrical Nerve Stimulator EUDAMED
Model / Reference
TENS Eco 2, TENS Eco, URO stim2, TENStem eco basic, TENS WMPS2-1,neurotech OmniTens XP+, neurotech PolyStim XP+, neurotech AvivaTens Plus EUDAMED
neurotech PolyStim XP+ EUDAMED
TENStem eco basic EUDAMED
URO stim2 EUDAMED

Identifiers

Primary DI / UDI-DI
06972011718172 EUDAMED
06972011718141 EUDAMED
06972011718127 EUDAMED
Basic UDI-DI
697201171B2000001GS EUDAMED
Direct Marketing DI
06972011718172 EUDAMED
06972011718141 EUDAMED
06972011718127 EUDAMED
510(k) Number
K231425 FDA 510(k)
FDA Product Code
NUH FDA 510(k)
EMDN Code
Z120622 MUSCLE STIMULATORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

The Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is a medical device classified as a transcutaneous electrical nerve stimulator, designed to deliver low-voltage electrical currents transcutaneously to modulate pain perception and facilitate muscle stimulation. It operates by applying gentle electrical impulses via surface electrodes to stimulate nerve fibers, thereby interfering with pain signals and promoting localized relief.

The WMPS2-1 is a lithium-battery-powered device supplied with an electronic stimulatory module, lead wires, adhesive electrodes, and an adapter. It features 16 programmable modes (12 standard, 4 editable) and an LCD display for user control. Intended for single-use or reusable application in clinical or home settings, it adheres to FDA 510(k) and MDR regulatory standards. Storage requires protection from moisture and extreme temperatures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Wmps2-1 Tens Unit - Tens and EMS, Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1), Tens Wmps 2-1transcutaneous Electrical Nerve and Muscle Stimulator ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Wuxi Jiajian Medical Instrument Co., Ltd.

Sources (4)

  • FDA 510(k) K231425 24 fields · synced Oct 6, 2026
  • EUDAMED 6b71801d-5db0-4766-8ab3-5ebf30f1251b 61 fields · synced Jul 11, 2026
  • EUDAMED 21a0523c-908c-401d-961a-8a03301114d4 61 fields · synced Jul 16, 2026
  • EUDAMED 2e41c00f-096c-443d-9c73-2f802389f632 61 fields · synced Jul 24, 2026