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Dr Ho's
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 183Model CP-IRef 188Model CP-III510(k) K200402
Identity
- Trade Name
- DR HO'S EUDAMED
- Device Name
- Circulation Promoter EUDAMEDCirculation Promoter Pro EUDAMED
- Model / Reference
- CP-I EUDAMED183 EUDAMEDCP-III EUDAMED188 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970742221831 EUDAMED06970742221886 EUDAMED
- Basic UDI-DI
- B-06970742221831 EUDAMEDB-06970742221886 EUDAMED
- 510(k) Number
- K200402 FDA 510(k)
- FDA Product Code
- GYB FDA 510(k)
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1275 FDA 510(k)
- Regulation Number
- 882.1275 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dr Ho's by Guangzhou Xinbo Electronic Co., Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200402 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970742221831 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Xinbo Electronic Co., Ltd
- EUDAMED SRN
- CN-MF-000012183
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 4fc7461e-b6f7-49c8-9733-62fae762231b 61 fields · synced Jun 20, 2026
- EUDAMED d13223a1-8ee1-4b33-aa04-6c52c6485791 61 fields · synced May 17, 2026
- FDA 510(k) K200402 24 fields · synced May 18, 2026