TENS and EMS (TENS and Muscle Stimulator) AS8012C, AS8016, AS8019, AS9020E, AS9026

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243856

Identifiers

510(k) Number: K243856 FDA 510(k)
FDA Product Code: NUH FDA 510(k)
Models / Variants: Model AS8012C FDA 510(k)EUDAMED
AS8016 FDA 510(k)EUDAMED
AS8019 FDA 510(k)EUDAMED
AS9020E FDA 510(k)EUDAMED
AS9026 FDA 510(k)EUDAMED

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)

This device is a Transcutaneous Electrical Nerve Stimulation (TENS) and Electromyostimulation (EMS) unit, designed to deliver low-voltage electrical impulses for pain management and muscle stimulation. It falls under the category of neuromuscular electrical stimulation devices, providing therapeutic modulation of nerve activity and muscle contraction through external electrode placement.

The TENS and EMS unit is supplied as a reusable medical device, intended for use in clinical and home settings under professional supervision or patient self-administration. Models AS8012C, AS8016, AS8019, AS9020E, and AS9026 are approved under FDA 510(k) clearance (K243856), EU MDR, and MDD compliance, with no third-party review. Sterility is not applicable; proper cleaning and maintenance are required between uses.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K243856	Class II	Active

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Manufacturer

Manufacturer: Shenzhen AsTec Technology Co., Ltd
FDA Applicant: Shenzhen Astec Technology Co., Ltd.

Sources (2)

FDA 510(k) K243856 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026