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Sign in to claim this brandWhat PHYSIO-ASSIST makes
Physio-Assist manufactures vacuum-assisted airway secretion-clearing systems designed to assist patients in clearing respiratory secretions. These devices include portable units like the TUB10 and TUB25, as well as larger systems such as the SIMEOX 200, which are intended for clinical use in managing airway obstruction.
The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Physio-Assist operates from the United States, adhering to applicable regulatory standards for these devices.
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 Physio-Assist manufacture?
Physio-Assist specializes in vacuum-assisted airway secretion-clearing systems. These devices are designed to help patients clear respiratory secretions, reducing airway obstruction. Examples include portable units like the TUB10 and TUB25, as well as larger clinical systems such as the SIMEOX 200.
Where is Physio-Assist based, and what regulatory standards do they follow?
Physio-Assist is based in the United States. While the company adheres to applicable regulatory standards for its devices, individual products must meet specific regulatory requirements—such as classification and clearance—to be authorized for use.
How are Physio-Assist’s devices classified under US regulations?
Physio-Assist’s devices fall under Class II classification in the US regulatory framework. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
Are Physio-Assist’s devices listed in any regulatory databases?
Yes, Physio-Assist’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing helps track and identify specific medical devices for regulatory, clinical, and supply chain purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 264454301
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tub10 | TUB-10 | FDA UDI | Class II | Active |
| Tub25 | TUB-25 | FDA UDI | N/A | Active |
| Simeox 200 | ACD-200 | FDA UDI | Class II | Active |
| Simeox 200 | ACD-200B | FDA UDI | Class II | Active |
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