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ZeroG-Passive System
EUDAMEDFDA UDIClass I (EU MDR)
Ref ZGP-110
by Aretech, LLC
Identity
- Trade Name
- ZeroG-Passive System FDA UDI
- Generic Name
- Gait rehabilitation frame, manual FDA UDI
- Device Name
- ZeroG-Passive System EUDAMEDThe ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use. FDA UDI
- Model / Reference
- ZGP-110 EUDAMEDFDA UDI
- Description
- The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018836067 EUDAMEDFDA UDI
- Basic UDI-DI
- 08500188360675 EUDAMED
- FDA Product Code
- IKX FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Gait rehabilitation frame, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Netherlands 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ZeroG-Passive System by Aretech, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08500188360675 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aretech, LLC
- EUDAMED SRN
- US-MF-000008500
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED c7a5cd51-7d90-4c06-bafc-7898d265367b 61 fields · synced Jun 19, 2026
- FDA UDI bf5c9a12-7843-4694-b13f-2c15d8b76d5d 34 fields · synced May 30, 2026