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Sign in to claim this brandWhat SELVAS Healthcare, Inc. makes
SELVAS Healthcare, Inc. manufactures bioelectrical body composition analysers, which measure body fat, muscle mass, and hydration levels using electrical impedance technology. They also produce automatic-inflation electronic sphygmomanometers designed for non-portable clinical use to accurately measure blood pressure.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
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 SELVAS Healthcare, Inc. manufacture?
SELVAS Healthcare, Inc. specializes in two primary categories of medical devices: bioelectrical body composition analysers and automatic-inflation electronic sphygmomanometers. The bioelectrical analysers use electrical impedance technology to assess body fat, muscle mass, and hydration levels, while the sphygmomanometers are designed for non-portable clinical use to measure blood pressure accurately.
Where is SELVAS Healthcare, Inc. based?
SELVAS Healthcare, Inc. is based in the United States. The company’s location is relevant for understanding its regulatory framework and compliance standards, particularly for devices marketed in the US.
How are SELVAS Healthcare, Inc.’s devices classified under FDA regulations?
SELVAS Healthcare, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to moderate-risk medical devices that require special controls to ensure their safety and effectiveness, such as those used for body composition analysis and blood pressure measurement.
Are SELVAS Healthcare, Inc.’s devices listed in any regulatory registries?
Yes, SELVAS Healthcare, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
What is the significance of SELVAS Healthcare, Inc.’s devices being Class II?
The Class II designation for SELVAS Healthcare, Inc.’s devices indicates they are subject to special controls beyond general controls, such as performance standards, post-market surveillance, or labeling requirements. This classification balances regulatory oversight with the need for innovation in moderate-risk devices like body composition analysers and sphygmomanometers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- selvashc.com
- —
- —
- [email protected]
- Phone
- +82428793024
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689700711
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accuniq | ACCUNIQ BP250 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BC390 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BC300 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BP210 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BC310 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BC360 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BC380 | FDA UDI | Class II | Active |
| Accuniq | ACCUNIQ BC730 | FDA UDI | Class II | Active |
| Accuniq | EV360 | FDA UDI | Class II | Active |
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