Apollo TMS Therapy System 230 V
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Apollo TMS Therapy System 230 V EUDAMED
- Model / Reference
- Apollo TMS Therapy System EUDAMED918000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260526050002 EUDAMED
- Basic UDI-DI
- 426052605APOLLO91836 EUDAMED
- Direct Marketing DI
- 04260526050002 EUDAMED
- EMDN Code
- Z12101105 MAGNETIC STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Apollo TMS Therapy System is a transcranial magnetic stimulation (TMS) device, classified under nomenclature code Z12101105. It delivers non-invasive magnetic pulses to stimulate neural activity in the brain, primarily used for therapeutic applications in neurology, such as treatment-resistant depression.
The system is non-sterile, non-reusable, and non-implantable, designed for clinical use in controlled environments. It operates on a 230 V power supply and includes a touchscreen interface for operator guidance. Regulated under FDA 510(k) clearance and MDR compliance, it is supplied as a single-use or multi-session device with specific UDI identifiers (e.g., 426052605APOLLO91836). Storage and handling follow manufacturer guidelines to ensure proper functionality and safety.
Frequently asked questions
What is the primary clinical focus of the Apollo TMS Therapy System, and how does it function in a clinical setting?
The Apollo TMS Therapy System is designed for therapeutic applications in neurology, specifically targeting treatment-resistant depression. It delivers non-invasive magnetic pulses to stimulate neural activity in the brain, helping modulate mood and alleviate symptoms. Since it is non-reusable and non-sterile, it is intended for use in controlled clinical environments where operators follow manufacturer guidelines for proper handling and functionality.
Is the Apollo TMS Therapy System meant for single-use or repeated sessions, and how is it powered?
The Apollo TMS Therapy System can be supplied for single-use or multi-session use, depending on the specific configuration. It operates on a 230 V power supply, ensuring stable performance for therapeutic procedures. The device includes a touchscreen interface to guide operators through sessions, which is particularly useful in clinical settings where precision and ease of use are critical.
What storage and handling precautions should be taken with the Apollo TMS Therapy System to maintain its functionality?
Since the Apollo TMS Therapy System is non-sterile and non-reusable, proper storage and handling are essential to preserve its performance. The manufacturer provides guidelines for storage conditions, which likely include protection from physical damage, extreme temperatures, and moisture. Adhering to these instructions ensures the device remains operational for its intended therapeutic use in neurology.
How is the Apollo TMS Therapy System regulated, and what does the nomenclature code Z12101105 indicate about its classification?
The Apollo TMS Therapy System is regulated under FDA 510(k) clearance and MDR compliance, confirming its adherence to safety and performance standards. The nomenclature code Z12101105 classifies it as a Class IIa device, indicating moderate risk and requiring specific regulatory oversight. This classification aligns with its use as a non-invasive, non-implantable therapeutic tool in neurology.
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: Apollo TMS Therapy by MAG & More - neurocare group, MAG & More GmbH | Leading TMS Systems Made in Germany, PDF Apollo TMS
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243700 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K243539 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232639 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180313 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426052605APOLLO91836 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MAG & More GmbH
- EUDAMED SRN
- DE-MF-000012125
Sources (2)
- EUDAMED 9ed84bc7-384e-4c1d-9982-9019022e9868 85 fields · synced Sep 18, 2026
- FDA 510(k) K243700 1 fields · synced May 18, 2026