Identifiers
- 510(k) Number
- K964873 FDA 510(k)
- FDA Product Code
- IOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5170 FDA 510(k)
- Regulation Number
- 890.5170 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a powered flotation therapy bed, classified as a Bed, Flotation Therapy, Powered under FDA device classification. It is designed for use in physical medicine applications to provide low air loss therapy for patient support and pressure redistribution.
It is supplied as a reusable device intended for use in healthcare settings such as hospitals, surgical centers, and home healthcare environments. The device received FDA 510(k) clearance (K964873) on July 3, 1997, is classified as Class II, and is regulated under regulation number 890.5170 with product code IOQ.
Frequently asked questions
What is the SILKAIR LOW AIRLOSS THERAPY used for?
The SILKAIR LOW AIRLOSS THERAPY is designed for use in physical medicine applications to provide low air loss therapy for patient support and pressure redistribution, helping to manage skin integrity and comfort during extended bed rest.
Is the SILKAIR LOW AIRLOSS THERAPY a reusable or single-use device?
The device is supplied as a reusable device intended for use in healthcare settings such as hospitals, surgical centers, and home healthcare environments, meaning it is designed for multiple patient uses after proper cleaning and maintenance between uses.
What regulatory pathway was used for the SILKAIR LOW AIRLOSS THERAPY?
The device received FDA 510(k) clearance (K964873) on July 3, 1997, through a traditional submission pathway, demonstrating substantial equivalence to a legally marketed predicate device.
What type of device is the SILKAIR LOW AIRLOSS THERAPY classified as?
The SILKAIR LOW AIRLOSS THERAPY is classified as a Bed, Flotation Therapy, Powered under FDA device classification, with product code IOQ and regulation number 890.5170, placing it in Class II for physical medicine applications.
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. Sources consulted: SILKAIR LOW AIRLOSS THERAPY (K964873) — FDA 510(k) | Innolitics, PDF K964873 - Silkair Low Airloss Therapy, Silkair Low Airloss Therapy - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964873 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (1)
- FDA 510(k) K964873 24 fields · synced Sep 26, 2026