ALTMS Magnetic Stimulation Therapy System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220625 FDA 510(k)
- FDA Product Code
- OBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5805 FDA 510(k)
- Regulation Number
- 882.5805 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ALTMS Magnetic Stimulation Therapy System is a Transcranial Magnetic Stimulator, classified as a Class II medical device. It delivers non-invasive cortical stimulation by generating brief, rapidly alternating magnetic fields via a ferromagnetic treatment coil, inducing targeted electrical currents in discrete regions of the cerebral cortex. This approach is designed to modulate neural activity for therapeutic purposes.
The system is supplied as a computerized, electromechanical device and is intended for use in clinical settings by trained healthcare professionals. It is regulated under FDA 510(k) clearance and MDR, with multiple registration numbers (e.g., 3005205657) and product codes (OBP). The device is not described as single-use or reusable in the specifications, and no MRI safety classification or sterility details are provided.
Frequently asked questions
What is the primary clinical application area for the ALTMS Magnetic Stimulation Therapy System, and how is it regulated in the U.S.?
The ALTMS Magnetic Stimulation Therapy System is primarily associated with neurology, as indicated by its advisory committee classification (NE) and medical specialty description. It is regulated in the U.S. under FDA 510(k) clearance with a Special clearance type, meaning it was determined to be substantially equivalent to a predicate device. The system is classified as a Class II medical device and is intended for use by trained healthcare professionals in clinical settings.
How is the ALTMS Magnetic Stimulation Therapy System supplied, and what should I consider regarding its maintenance or reuse?
The ALTMS Magnetic Stimulation Therapy System is supplied as a computerized, electromechanical device, meaning it is not a single-use or disposable item. Since the data does not specify sterility or MRI safety classifications, it is intended for repeated use in clinical environments under proper maintenance protocols. The manufacturer, REMED Co., Ltd., would provide guidelines for cleaning, calibration, and upkeep to ensure safe and effective operation.
Are there multiple models or configurations of the ALTMS Magnetic Stimulation Therapy System, and how can I verify regulatory compliance?
The ALTMS Magnetic Stimulation Therapy System includes multiple registration numbers (e.g., 3005205657) and OpenFDA identifiers, suggesting there may be variations or updates within the product line. To verify regulatory compliance, you can reference the FDA’s OpenFDA database using the provided registration numbers or check the EU MDR compliance if applicable. The system is also listed under the product code OBP, which may help in identifying specific variants or configurations.
What should I know about the storage or handling of the ALTMS Magnetic Stimulation Therapy System to ensure optimal performance?
The provided data does not specify storage conditions, but as an electromechanical device, it should be stored in a clean, dry environment protected from extreme temperatures, humidity, and physical damage. Since it is not described as sterile or MRI-safe, it should be kept away from magnetic interference sources. Always follow the manufacturer’s instructions for setup, calibration, and maintenance to maintain performance and safety.
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: ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System ..., Blossom TMS Therapy System, ALTMS Magnetic Stimulation Therapy System (K202537) — FDA 510(k ..., PDF November 26, 2021 REMED Co., Ltd Kyungyoon Kang CEO K-Biotech Trade ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220625 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- REMED Co., Ltd.
Sources (2)
- FDA 510(k) K220625 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026