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Anti-Shock Trousers

by Simulaids, Inc.

510(k) K873997

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 NumberK873997 Date15 Dec 1987ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

Anti-shock trousers are a medical device used to treat severe blood loss by applying external pressure to the pelvis, abdomen, and lower body via inflatable air bladders. The device functions as a pneumatic anti-shock garment (PASG) to help stabilize patients in emergency situations.

The trousers are supplied as a reusable unit and include components such as a pump, case, handle, instruction guide, serviceable label, and repair kit. They were cleared by the FDA under 510(k) submission K873997 on December 15, 1987, and are classified as a Class II device under regulation number 870.5800 with product code JOW.

Questions

AI-generated answers, 28 Sep 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 primary medical use of the anti-shock trousers?

    The anti-shock trousers are used to treat severe blood loss by applying external pressure to the pelvis, abdomen, and lower body via inflatable air bladders, functioning as a pneumatic anti-shock garment (PASG) to help stabilize patients in emergency situations.

  • Are the anti-shock trousers reusable or single-use?

    The anti-shock trousers are supplied as a reusable unit, meaning they are designed for multiple uses after proper cleaning and maintenance, as indicated by the inclusion of a serviceable label and repair kit in the supplied components.

  • What components are included with the anti-shock trousers when supplied?

    The anti-shock trousers are supplied as a reusable unit and include a pump, case, handle, instruction guide, serviceable label, and repair kit, which together support the device's operation, maintenance, and longevity in clinical or emergency settings.

  • What regulatory pathway was used for the anti-shock trousers, and what is their classification?

    The anti-shock trousers were cleared by the FDA under a 510(k) submission (K873997) on December 15, 1987, and are classified as a Class II medical device under regulation number 870.5800 with product code JOW, indicating they were found substantially equivalent to a legally marketed predicate device.