Combo Electrotherapy Device

by Shenzhen Roundwhale Technology Co., Ltd. 7 variants

Part of a family of 35 devices: see the family page

Ref R-C101BModel R-C1(MEX1/RW1/SA3), R-C3, R-C101A~L/W, R-C4A(AUS1/RW1~RW3/U12), R-C4B(AUS12/DE4/RW1), R-C4C(AUS1), R-C4D(RW1/U7/U9/WH1), R-E1, R-T1, F100, M100A(WH1), M101A(UK1/WH2), M102A, M103A, M104A, MINI-TENS-COMB, TENS3500

Combo Electrotherapy Device (R-C101B) is a transcutaneous electrical stimulation probe (EU MDR Class IIa; FDA Class II) made by Shenzhen Roundwhale Technology Co. Ltd., cleared under FDA 510(k) K231440 on 3 Nov 2023, registered in EUDAMED on 29 Oct 2022 (Basic UDI-DI 697176360CE000173) and listed in FDA GUDID since 31 Jul 2024 (UDI-DI 06971763600506), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231440

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number06971763600506 UDI-DI	Date31 Jul 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK231440	Date3 Nov 2023Decided	StatusActive
European Union	CE/MDR EUDAMED	Number697176360CE000173 Basic UDI-DI 06971763600506UDI-DI	Date29 Oct 2022Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 697176360CE000173 — open Devices and search for it
AccessGUDID record UDI-DI 06971763600506
FDA 510(k) database 510(k) number K231440

Across registries

3 registries list this device

FDA 510(k) K231440 decided 3 Nov 2023 Active
EUDAMED Basic UDI-DI 697176360CE000173 registered 29 Oct 2022 Active
FDA GUDID UDI-DI 06971763600506 listed 31 Jul 2024 Listed

Timeline

3 dated events

29 Oct 2022 Registered EUDAMED 697176360CE000173
3 Nov 2023 Cleared FDA 510(k) K231440
31 Jul 2024 Listed FDA GUDID 06971763600506

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Combo Electrotherapy Device EUDAMED
Roovjoy GUDID
Generic name: Transcutaneous electrical stimulation probe
Model / reference: R-C1(MEX1/RW1/SA3), R-C3, R-C101A~L/W, R-C4A(AUS1/RW1~RW3/U12), R-C4B(AUS12/DE4/RW1), R-C4C(AUS1), R-C4D(RW1/U7/U9/WH1), R-E1, R-T1, F100, M100A(WH1), M101A(UK1/WH2), M102A, M103A, M104A, MINI-TENS-COMB, TENS3500, R-C101B

Primary DI / UDI-DI: 06971763600506
Basic UDI-DI: 697176360CE000173
Direct marketing DI: 06971763600506
FDA product code: GZJ, IPF, LIH
EMDN code: Z120622 Muscle stimulators
GMDN term: Transcutaneous electrical stimulation probe

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 882.5890, 890.5850
System or procedure pack: System which is a device in itself
EU registration type: Standard device
EU market of registration: Spain
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN: CN-MF-000021504
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under MUSCLE STIMULATORS.

Other devices from Shenzhen Roundwhale Technology Co. Ltd.

See all devices from Shenzhen Roundwhale Technology Co. Ltd. →

Properties

Lot / batch number
Manufacturing date

Other properties (23, all answered No)