Identifiers
- 510(k) Number
- K890523 FDA 510(k)
- FDA Product Code
- INX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5160 FDA 510(k)
- Regulation Number
- 890.5160 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SUPERCAIR is an air fluidized bed, a device type used in physical medicine for patient support and pressure redistribution. It is designed to provide therapeutic support through fluidized air circulation.
The device is supplied as a reusable system intended for use in clinical settings. It has received FDA 510(k) clearance under product code INX and regulation number 890.5160, with a traditional clearance pathway and SESE decision code.
Frequently asked questions
What is the SUPERCAIR used for?
The SUPERCAIR is an air fluidized bed used in physical medicine for patient support and pressure redistribution, providing therapeutic support through fluidized air circulation to help manage pressure-related skin integrity in clinical environments.
Is the SUPERCAIR reusable or single-use?
The SUPERCAIR is supplied as a reusable system intended for repeated use in clinical settings, meaning it is designed to be cleaned, maintained, and used multiple times following manufacturer guidelines for safe operation.
How was the SUPERCAIR cleared for market?
The SUPERCAIR received FDA 510(k) clearance through a traditional submission pathway, demonstrating substantial equivalence to a legally marketed predicate device under product code INX and regulation number 890.5160.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890523 | Class II | Active |
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Manufacturer
- Manufacturer
- Ssi Medical Services, Inc.
Sources (1)
- FDA 510(k) K890523 24 fields · synced Sep 23, 2026