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Revitive Circulation Booster
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 12120-5575AQ-FR
Identity
- Trade Name
- Revitive Circulation Booster EUDAMEDRevitive Medic Coach FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Revitive Medic Coach EUDAMEDNeuromuscular Electrical Stimulation Device FDA UDI
- Model / Reference
- 12120-5575AQ-FR EUDAMED5575AQ FDA UDI
- Description
- Neuromuscular Electrical Stimulation Device FDA UDI
Identifiers
- Catalog Number
- 5921 FDA UDI
- Primary DI / UDI-DI
- 00858058005221 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00858058005221 EUDAMED
- 510(k) Number
- K210825 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDIIPF FDA UDINYN FDA UDIGZJ FDA UDI
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Revitive Circulation Booster by Actegy Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00858058005221 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Actegy Limited
- EUDAMED SRN
- GB-MF-000032543
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 680f7595-26ca-47bf-8587-014578cfa9e4 61 fields · synced Jul 13, 2026
- FDA UDI 223367b8-2d3a-40a9-b891-1eee77cc664d 37 fields · synced May 30, 2026