# Combo Electrotherapy Device

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/combo-electrotherapy-device-r-c101b>
- Manufacturer: [Shenzhen Roundwhale Technology Co., Ltd.](https://devicerts.com/manufacturers/fda-fei-3014314933) (China)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: GZJ, IPF, LIH
- EMDN: Z120622 MUSCLE STIMULATORS
- GMDN: Transcutaneous electrical stimulation probe (61169)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 06971763600506 · listed 2024-07-31 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K231440 · decision 2023-11-03 · decision SESE · status: Active · from GUDID
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 697176360CE000173 · UDI-DI 06971763600506 · registered 2022-10-29 · status: Active

## Recalls

No recall on record.

## Identity

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

## Identifiers

- Primary DI / UDI-DI: 06971763600506 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 697176360CE000173 [EUDAMED]
- Direct marketing DI: 06971763600506 [EUDAMED]
- FDA product code: GZJ [FDA GUDID (AccessGUDID)]; IPF [FDA GUDID (AccessGUDID)]; LIH [FDA GUDID (AccessGUDID)]
- EMDN code: Z120622 [EUDAMED]
- GMDN term: Transcutaneous electrical stimulation probe (61169) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.5890 [FDA GUDID (AccessGUDID)]; 890.5850 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Spain [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Combo Electrotherapy Device, Shenzhen Roundwhale Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/combo-electrotherapy-device-r-c101b (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/combo-electrotherapy-device-r-c101b.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/combo-electrotherapy-device-r-c101b
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.