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SCD Knee Immobilizer

by Kendall Healthcare Products Co. Div.Of Tyco Health

510(k) K895278

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895278 Date30 Nov 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOW
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SCD Knee Immobilizer is a sleeve, limb, compressible device designed to immobilize the knee joint while maintaining controlled compression. It is classified as a Class II medical device and is intended to support the knee during sequential compression therapy to reduce the risk of venous thromboembolism (VTE).

This device is supplied as a reusable, non-sterile sleeve and is intended for use in clinical settings such as hospitals and outpatient care facilities. It is compatible with sequential compression devices (SCDs) and is regulated under FDA 510(k) clearance (K895278) with a traditional review pathway. The device adheres to regulatory standards outlined in 870.5800 and is categorized under the product code JOW, with advisory committee review in the cardiovascular specialty.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SCD Knee Immobilizer used for?

    The SCD Knee Immobilizer is designed to immobilize the knee joint while applying controlled compression. It is intended for use during sequential compression therapy (SCD) to help reduce the risk of venous thromboembolism (VTE) in clinical settings like hospitals or outpatient care facilities.

  • Is the SCD Knee Immobilizer reusable or single-use?

    The SCD Knee Immobilizer is supplied as a reusable device. It is intended for repeated use in clinical environments, provided proper cleaning and maintenance protocols are followed.

  • Is the SCD Knee Immobilizer sterile?

    No, the SCD Knee Immobilizer is supplied in a non-sterile condition. It is intended for use in clinical settings where standard infection control practices can be applied.

  • What sizes or models are available for the SCD Knee Immobilizer?

    The SCD Knee Immobilizer is listed under multiple registration numbers (e.g., 3029923680, 3009211636, etc.), which may correspond to different sizes or variations. For precise sizing details, refer to the manufacturer’s documentation or contact Kendall Healthcare Products.

  • How should the SCD Knee Immobilizer be stored?

    Since the device is reusable and non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for cleaning and maintenance to ensure proper functionality and hygiene.