Reprocessed Compression Garments
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K161105 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reprocessed Compression Garment is the sleeve component of a pneumatic compression system intended to apply circumferential pressure to a patient's leg. It is classified as a Sleeve, Limb, Compressible device under the Cardiovascular medical specialty.
This Class 2 device was cleared via the FDA 510(k) pathway under K161105 with product code JOW and regulation number 870.5800. It is manufactured by Covidien and determined to be substantially equivalent to a predicate device.
Frequently asked questions
What is the Reprocessed Compression Garment used for?
The Reprocessed Compression Garment is the sleeve component of a pneumatic compression system intended to apply circumferential pressure to a patient's leg, as it is classified as a Sleeve, Limb, Compressible device under the Cardiovascular medical specialty.
How is the Reprocessed Compression Garment supplied or regulated?
This Class 2 device was cleared via the FDA 510(k) pathway under K161105 with product code JOW and regulation number 870.5800, and is manufactured by Covidien as substantially equivalent to a predicate device.
What regulatory pathway was used for the Reprocessed Compression Garment?
The device received clearance through the FDA's Traditional 510(k) pathway, as indicated by the clearance_type field, and was found substantially equivalent to a predicate device under K161105.
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: K161105 FDA 510 (k) - Reprocessed Compression Garments | Covidien, Reprocessed Compression Garments (K161105) — FDA 510(k) | Innolitics, PDF Reprocessed Compression Garments 510 (k) K161105 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161105 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K161105 24 fields · synced Sep 27, 2026