Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231423

by Shenzhen Roundwhale Technology Co. Ltd.

Identifiers

510(k) Number: K231423 FDA 510(k)
FDA Product Code: NUH FDA 510(k)
Models / Variants: Models: R-C101C FDA 510(k)EUDAMED
R-C101D FDA 510(k)EUDAMED
R-C101F FDA 510(k)EUDAMED
R-C101G FDA 510(k)EUDAMED
F100 FDA 510(k)EUDAMED
MINI-TENS-COMB FDA 510(k)EUDAMED
RC101I FDA 510(k)EUDAMED
TENS3500 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)

The Combo Electrotherapy Device is a transcutaneous electrical nerve stimulation (TENS) and electromyostimulation (EMS) unit designed to deliver low-voltage electrical currents for pain management and muscle stimulation. It combines TENS therapy, which modulates pain signals via cutaneous electrodes, with EMS, which facilitates muscle contraction and relaxation through targeted electrical impulses. The device is classified under electrotherapy modalities for neuromuscular and pain relief applications.

This device is supplied as a reusable, non-sterile medical instrument intended for professional or home use under clinical supervision. It operates within regulatory frameworks, including FDA 510(k) clearance and EU MDR compliance, and is categorized under product code NUH. Models vary in size and functionality, with specific configurations for TENS, EMS, or combined use, and must be stored in a clean, dry environment to maintain operational integrity. No MRI safety information is specified.

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: Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G ..., Combo Electrotherapy Device (Models: R-C101C… - FDA.report, trendmedic TENS-EMS R-C101C Instruction Manual

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K231423	Class II	Active

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Manufacturer

Manufacturer: Shenzhen Roundwhale Technology Co. Ltd.
FDA Applicant: Shenzhen Roundwhale Technology Co. , Ltd.

Sources (2)

FDA 510(k) K231423 24 fields · synced Sep 20, 2026
EUDAMED 1 fields · synced May 18, 2026