ZT Clinic (MG675A) +2 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Z-ONE EUDAMED
- Device Name
- Z-ONE EUDAMED
- Model / Reference
- MG455BA00E EUDAMEDMG455BA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894530427 EUDAMED
- Basic UDI-DI
- B-03858894530427 EUDAMED
- 510(k) Number
- K242754 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
These devices are Powered Inflatable Tube Massagers, designed for physical medicine applications. They deliver controlled pneumatic pressure to targeted body areas, facilitating therapeutic interventions such as muscle relaxation, edema reduction, and lymphatic drainage through inflatable tubes compatible with thermal wraps for various anatomical regions, including the leg, shoulder, thigh, knee, calf, elbow, wrist, ankle, and hip.
The devices are intended for clinical use in settings such as physical therapy or rehabilitation facilities. Supplied as reusable medical equipment, they operate within a temperature range of 0°C to +45°C and are regulated under FDA 510(k) clearance (K242754) and the Medical Device Directive (MDD). Each model (MG675A, MG465A, MG455A) may vary in capacity, with the ZT Clinic supporting up to four simultaneous wraps. No MRI safety or single-use specifications are indicated.
Frequently asked questions
What clinical applications are these devices primarily used for in physical medicine settings?
These devices—ZT Clinic (MG675A), ZT Cube (MG465A), and Z-ONE (MG455A)—are designed for muscle relaxation, edema reduction, and lymphatic drainage through controlled pneumatic pressure delivered via inflatable tubes. They are compatible with thermal wraps and target specific anatomical regions like the leg, shoulder, thigh, knee, calf, elbow, wrist, ankle, and hip, making them ideal for physical therapy or rehabilitation to aid recovery and reduce swelling.
Are these devices single-use or reusable, and how should they be maintained?
These devices are reusable medical equipment, not single-use. Since they operate within a temperature range of 0°C to +45°C, proper storage and cleaning per manufacturer guidelines are essential to maintain functionality and hygiene. The data does not specify cleaning protocols, so facility-specific protocols should align with standard infection control practices for reusable pneumatic therapy devices.
How many wraps can each model support simultaneously, and what are the key differences between the ZT Clinic, ZT Cube, and Z-ONE?
The ZT Clinic (MG675A) is the only model explicitly noted to support up to four simultaneous wraps, while the ZT Cube (MG465A) and Z-ONE (MG455A) likely support fewer (though exact capacities aren’t detailed). The primary distinction lies in capacity and possibly portability or intended clinical workflows—e.g., the Clinic may be designed for multi-patient or multi-region use, while the Cube and Z-ONE may prioritize compactness or single-region focus. All share the same pneumatic tube technology for targeted pressure therapy.
Can these devices be used in an MRI environment, and what storage conditions are recommended?
The data does not mention MRI safety certifications or compatibility, so these devices should not be assumed safe for MRI environments without explicit confirmation from the manufacturer. For storage, they are rated for 0°C to +45°C, so they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality and prevent damage to pneumatic components.
What regulatory pathways have these devices followed, and how does that affect their use in clinical settings?
These devices are cleared under FDA 510(k) (K242754) and comply with the Medical Device Directive (MDD), indicating they meet U.S. and EU standards for substantial equivalence to predicate devices in Physical Medicine. This clearance confirms their safety and effectiveness for powered inflatable tube massagers as described, but clinicians should verify local compliance requirements (e.g., facility licensing, staff training) before integration into therapy protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (K242754 ..., ZTCLINIC - ZAMAR Medical, ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242754 | Class II | Active |
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Manufacturer
- Manufacturer
- Zamar Medical D.O.O.
Sources (2)
- FDA 510(k) K242754 24 fields · synced Oct 6, 2026
- EUDAMED a1acb259-f45f-4624-bd58-db3db3951cc3 61 fields · synced Jul 21, 2026