Polar Pad (Sterile)
FDA 510(k)Class II (US FDA 510(k))
by Breg, Inc.
Identifiers
- 510(k) Number
- K920581 FDA 510(k)
- FDA Product Code
- ILO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5720 FDA 510(k)
- Regulation Number
- 890.5720 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Pack, Hot Or Cold, Water Circulating, as defined in the nomenclature authority. It is a sterile polar pad designed for use with cold therapy systems.
It is supplied sterile and intended for use with the Polar Care Glacier, Cube, and Cub systems. An insulation barrier must be used between the pad and the patient's skin during application. The device has received FDA 510(k) clearance under K920581 and is classified as a Class II medical device.
Frequently asked questions
What is the POLAR PAD (STERILE) intended for?
The POLAR PAD (STERILE) is a sterile pack designed for hot or cold water circulating therapy, intended for use with the Polar Care Glacier, Cube, and Cub systems to deliver temperature therapy to patients.
How is the POLAR PAD (STERILE) supplied and is it sterile?
The device is supplied sterile and intended for single-use applications; it must remain sterile until point of use and is not designed for reprocessing or reuse after initial application.
What precautions are required when using the POLAR PAD (STERILE)?
An insulation barrier must be used between the pad and the patient's skin during application to prevent direct contact and potential thermal injury, as specified in the device description.
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: Polar Pads - Breg, Inc., Breg® Rectangle Polar Pads + Sterile Dressings by Breg from 44.99 at ..., Breg® Polar Care Cube & Glacier Large Rectangle Polar Pads + Sterile ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920581 | Class II | Active |
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Manufacturer
- Manufacturer
- Breg, Inc.
Sources (1)
- FDA 510(k) K920581 24 fields · synced Sep 24, 2026