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Leg Holder (HRX)

by American Container Technology, Inc.

510(k) K864476

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 NumberK864476 Date15 Dec 1986ClearedStatusActive

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  • Withdrawn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)

Full name
Leg Holder
510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Leg Holder (HRX) is a medical device classified under the product code HRX, designed to immobilize and support a patient’s leg during orthopedic procedures or postoperative care. It is intended for use in clinical settings where stable positioning of the lower limb is required, such as during surgical interventions or rehabilitation.

This device is supplied as a reusable medical instrument and is regulated under an FDA 510(k) clearance (K864476) granted in 1986. It is intended for use in orthopedic settings and must be cleaned and maintained according to standard medical device reprocessing protocols. No additional sterility or MRI safety information is specified in the available data.

Other devices from American Container Technology, Inc.

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the Leg Holder designed for single-use or can it be reused in a clinical setting?

    The Leg Holder (HRX) is explicitly supplied as a reusable medical instrument. Since it is classified under FDA product code HRX and requires reprocessing, it must be cleaned and maintained according to standard medical device reprocessing protocols to ensure safety and functionality for repeated use.

  • What types of procedures or settings is this device intended for?

    The Leg Holder (HRX) is designed to immobilize and support a patient’s leg during orthopedic procedures or postoperative care. It is specifically intended for clinical settings where stable positioning of the lower limb is required, such as during surgical interventions or rehabilitation.

  • How is the device regulated, and when was it cleared by the FDA?

    The Leg Holder (HRX) is regulated under an FDA 510(k) clearance with the designation K864476, granted on December 15, 1986. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the Orthopedic advisory committee category.

  • Does the Leg Holder come in different sizes or models?

    The provided data does not specify sizes or models for the Leg Holder (HRX). However, since it is a reusable orthopedic device, variations in design (e.g., adjustable straps, padding, or leg circumference compatibility) may exist, but these details are not explicitly listed in the available documentation.

  • Are there any special storage requirements for this device?

    The Leg Holder (HRX) is a reusable device, so its storage should follow standard protocols for reusable medical instruments, including cleaning, disinfection, and proper environmental conditions to prevent contamination or damage. However, the data does not specify any unique storage requirements beyond general reprocessing guidelines.