← Back to catalogue
Z-Ems Zionic Pro Max Hp 2
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref A498/2Model Z-EMS ZIONIC PRO MAX HP 2
Identity
- Device Name
- Z-EMS ZIONIC PRO MAX HP 2 EUDAMED
- Model / Reference
- Z-EMS ZIONIC PRO MAX HP 2 EUDAMEDA498/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436601291387 EUDAMED
- Basic UDI-DI
- 843660129ZPEMSHP2H2 EUDAMED
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
Classification
- Device Class
- Class IIb 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
Z-Ems Zionic Pro Max Hp 2 by Termosalud, S.L. — Class IIb — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253636 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 843660129ZPEMSHP2H2 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
Sources (2)
- EUDAMED 667db2f5-d156-4faa-b7b2-fcb0fa9f8065 61 fields · synced Jun 19, 2026
- FDA 510(k) K253636 1 fields · synced May 18, 2026