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Isostation Ankle/Subtalar Machine A-100

by Isotechnologies, Inc.

510(k) K844060

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 NumberK844060 Date23 Nov 1984ClearedStatusActive

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  • Withdrawn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
IKK
Device Class
Class II
Regulation
21 CFR Part 890.1925
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Isostation Ankle/Subtalar Machine A-100 is an electrohydraulic rehabilitation machine designed for isokinetic testing and evaluation. It permits active and passive movements in three dimensions for the rehabilitation of muscular deficits due to trauma, disuse, disease, accidents, or chronic musculoskeletal disorders in athletes and the aged.

The device is supplied as a system for use in physical medicine settings. It received FDA 510(k) clearance (K844060) on November 23, 1984, and is classified as a Class II device under regulation number 890.1925 with product code IKK.

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