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Sign in to claim this brandPHYSIQ, INC
US
Last updated May 24, 2026
What PHYSIQ, INC makes
PhysIQ, Inc. manufactures electrocardiography (ECG) telemetric monitoring systems designed for remote patient monitoring. Their portfolio includes patient kits for continuous heart rhythm tracking, an Android application for data access, and a personalized analytics engine for interpreting physiological data.
The company’s devices are classified under FDA categories Class I and Class II, with authorisations granted via 510(k) clearances and inclusion in the FDA’s Unique Device Identifier (UDI) database. These products are regulated under US medical device laws and are listed in the FDA’s regulatory registries.
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 PhysIQ, Inc. manufacture?
PhysIQ, Inc. specializes in electrocardiography (ECG) telemetric monitoring systems. Their primary focus is on remote patient monitoring solutions, including portable patient kits for continuous heart rhythm tracking and an Android app for accessing patient data. They also offer a personalized analytics engine to interpret physiological data collected from these devices.
Where is PhysIQ, Inc. based, and how does that affect its regulatory oversight?
PhysIQ, Inc. is based in the United States, which means its devices are subject to FDA regulation under US medical device laws. Since the company operates within the US, its products must comply with FDA requirements for classification, clearance, and listing in regulatory databases like the UDI system.
Which regulatory registries list PhysIQ, Inc.’s devices, and why does this matter?
PhysIQ, Inc.’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) database. Inclusion in these registries confirms that the devices have undergone the necessary regulatory review process for compliance with US medical device standards. The UDI listing also ensures traceability and transparency in the supply chain.
How are PhysIQ, Inc.’s devices classified by the FDA, and what does that classification mean?
PhysIQ, Inc.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls for regulation, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny required for each device type.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- physiq.com
- —
- —
- [email protected]
- Phone
- +1 855-869-9054
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079107007
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| physIQ Patient Kit | Model I | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model Q | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model B | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model O | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model G | FDA UDI | N/A | Active |
| physIQ Android App | 3.4 (Edison) | FDA UDI | Class I | Active |
| physIQ Patient Kit | Model M | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model AD | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model T | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model D | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model C | FDA UDI | N/A | Active |
| physIQ Personalized Physiology Analytics Engine | 2 | FDA UDI | Class II | Active |
| physIQ Heart Rhythm and Respiration Module | 3 | FDA UDI | Class II | Active |
| physIQ Patient Kit | Model R | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model U | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model S | FDA UDI | N/A | Active |
| physIQ UI (accelerateIQ) | 4.4 (Golan) | FDA UDI | Class I | Active |
| physIQ Patient Kit | Model N | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model K | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model F | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model A | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model AC | FDA UDI | N/A | Active |
| physIQ Cloud Platform | 3.2 (Deneb) | FDA UDI | Class I | Active |
| physIQ Patient Kit | Model E | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model H | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model AB | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model Z | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model L | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model P | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model J | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model W | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model AA | FDA UDI | N/A | Active |
| physIQ UI (pinpointIQ) | 4.4 (Golan) | FDA UDI | Class I | Active |
| physIQ Patient Kit | Model Y | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model X | FDA UDI | N/A | Active |
| physIQ Patient Kit | Model V | FDA UDI | N/A | Active |
| physiQ Heart Rhythm Module | K180234 | FDA 510(k) | Class II | Active |
| physIQ Heart Rhythm and Respiratory Module | K183322 | FDA 510(k) | Class II | Active |
| physIQ Heart Rhythm and Respiration Module | K193415 | FDA 510(k) | Class II | Active |
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