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Mini TENS Therapy Device (K182871)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K182871

by Shenzhen Jumper Medical Equipment Co., Ltd.

Identifiers

510(k) Number
K182871 FDA 510(k)
FDA Product Code
NUH FDA 510(k)

Classification

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

The Mini TENS Therapy Device is a transcutaneous electrical nerve stimulation (TENS) unit, designed to provide non-invasive pain relief through low-voltage electrical currents applied to the skin. It falls under the classification of a neuromodulation device, delivering therapeutic stimulation for acute or chronic pain management in clinical and home settings.

This device is supplied as a reusable, non-sterile medical instrument, intended for use in outpatient or home environments. It operates under FDA 510(k) clearance (K182871) and EU MDR compliance, with no MRI safety restrictions specified. Storage requires protection from moisture and physical damage; no single-use components are indicated.

Frequently asked questions

What types of pain conditions is the Mini TENS Therapy Device intended to help manage, and how does it work?

The Mini TENS Therapy Device is designed for non-invasive pain relief through transcutaneous electrical nerve stimulation (TENS). It delivers low-voltage electrical currents to the skin, which can help manage acute or chronic pain by modulating nerve signals. While it is not specified for any particular condition, it is commonly used for general pain relief in clinical or home settings, such as musculoskeletal pain, postoperative pain, or neuropathic discomfort.

Is the Mini TENS Therapy Device meant for single-use or can it be reused? How should it be stored?

The Mini TENS Therapy Device is explicitly labeled as a reusable, non-sterile instrument. To maintain its functionality and safety, it should be stored in a dry environment, protected from moisture and physical damage. Since it is not sterile, it should not be used in sterile medical procedures.

What regulatory approvals does the Mini TENS Therapy Device hold, and how does this affect its use?

The Mini TENS Therapy Device holds both FDA 510(k) clearance (K182871) and EU MDR compliance, confirming its safety and performance for neuromodulation purposes. This means it can legally be marketed and used in the U.S. and EU under the specified indications for pain relief, adhering to the respective regulatory standards.

Are there any special considerations for using the Mini TENS Therapy Device, such as MRI safety or compatibility with other devices?

The Mini TENS Therapy Device does not have any specified MRI safety restrictions, meaning it can be used in environments where MRI scans are performed without direct interference. However, since it involves electrical stimulation, it should not be used on patients with pacemakers, implanted defibrillators, or other implanted electronic devices unless explicitly approved by a physician.

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: TENS Therapy Device - Shenzhen Jumper Medical Equipment Co., Ltd., Jumper Medical - Supplier of Household Medical Devices, JUMPER, Mini TENS Therapy Device (K182871) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd.

Sources (2)

  • FDA 510(k) K182871 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026