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ForceGuard

by Impact Monitors, Inc.

510(k) K955034

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955034 Date10 Apr 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
IRN
Device Class
Class II
Regulation
21 CFR Part 890.5575
Advisory Committee
Physical Medicine
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 ForceGuard is a Powered External Limb Warning, Overload Device (IRN product code) designed to protect limbs from excessive force during physical therapy or rehabilitation. It operates by monitoring and alerting users to potential overload conditions, helping prevent injury during stretching or resistance exercises in physical medicine settings.

ForceGuard is supplied as a reusable device and is intended for use in clinical environments where controlled limb movement is required. It is classified as a Class 2 device under FDA regulations (890.5575) and was cleared via the Traditional 510(k) pathway (K955034) in 1996. No specific sterility or MRI safety information is provided in the available data.

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 ForceGuard designed to do in physical therapy?

    The ForceGuard is a Powered External Limb Warning, Overload Device that continuously monitors limb movement during stretching or resistance exercises. It detects when applied force exceeds safe thresholds and alerts users to prevent injury, ensuring controlled rehabilitation in clinical settings.

  • Is the ForceGuard reusable or single-use?

    The ForceGuard is explicitly supplied as a reusable device, intended for repeated use in clinical environments where controlled limb movement is required. This design reduces waste and supports long-term patient care without requiring disposal after each session.

  • What regulatory pathway was used for FDA clearance of the ForceGuard?

    The ForceGuard was cleared via the Traditional 510(k) pathway under the FDA’s IRN product code category (IRN), which covers Powered External Limb Warning, Overload Devices. It was determined substantially equivalent to a predicate device and received clearance on April 10, 1996, under K-number K955034.

  • Does the ForceGuard require sterilization before use?

    The available data does not specify any sterility requirements for the ForceGuard. Since it is designed for reusable clinical use, standard infection control protocols (e.g., cleaning and disinfection between patients) should be followed, though no explicit sterility claims or MRI safety information are provided.

  • What type of clinical setting is the ForceGuard intended for?

    The ForceGuard is intended for use in physical medicine settings where controlled limb movement is critical, such as physical therapy or rehabilitation clinics. Its purpose is to enhance safety during exercises that involve stretching or resistance, helping clinicians prevent overload-related injuries during patient care.