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Combo Electrotherapy Device
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref R-C4A-RW2Model Combo Electrotherapy Device510(k) K192087
Identity
- Trade Name
- Combo Electrotherapy Device EUDAMED
- Device Name
- Combo Electrotherapy Device EUDAMED
- Model / Reference
- Combo Electrotherapy Device EUDAMEDR-C4A-RW2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763600810 EUDAMED
- Basic UDI-DI
- 697176360CE000173 EUDAMED
- Direct Marketing DI
- 06971763600810 EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Combo Electrotherapy Device by Shenzhen Roundwhale Technology Co. Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192087 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697176360CE000173 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Roundwhale Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021504
- FDA Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b2eecab4-ce5f-4f24-9bc3-128b038b6d88 85 fields · synced Jun 19, 2026
- FDA 510(k) K192087 1 fields · synced May 19, 2026