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Sign in to claim this brandSwing Therapeutics, Inc.
US
Last updated May 30, 2026
What Swing Therapeutics, Inc. makes
Swing Therapeutics develops software-based mental health interventions designed for screen-viewed use, focusing on therapeutic applications for cognitive and emotional function. The platform includes digital tools aimed at structured, guided sessions to support users in managing mental health conditions.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearances and the Unique Device Identifier (UDI) system. These devices are intended for use within the United States, adhering to FDA compliance requirements for software-as-a-medical-device (SaMD) applications.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Swing Therapeutics, Inc. manufacture?
Swing Therapeutics, Inc. specializes in developing mental health/function therapeutic software designed for screen-viewed use. These devices are software-based interventions aimed at improving cognitive and emotional function through structured, guided sessions. The company’s focus is on digital therapeutic tools intended to support users in managing mental health conditions.
Where is Swing Therapeutics, Inc. based, and where are its devices intended for use?
Swing Therapeutics, Inc. is based in the United States. Its devices are specifically intended for use within the U.S. market, where they must comply with FDA regulations for software-as-a-medical-device (SaMD) applications.
How are Swing Therapeutics’ devices classified under FDA regulations?
Swing Therapeutics’ devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software-based therapeutic interventions for mental health.
Which regulatory registries or databases list Swing Therapeutics’ devices?
Swing Therapeutics’ devices are listed in the FDA’s 510(k) clearance database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices that have undergone the necessary regulatory pathways, such as 510(k) clearances for Class II devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rbc-group.org
- —
- —
- [email protected]
- Phone
- 2074504228
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117470599
Catalogue (5)
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