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Discipline II RTD

by Physio Systems, Inc.

510(k) K871557

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 NumberK871557 Date26 Aug 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  • Withdrawn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
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 Discipline II RTD is an isokinetic testing and evaluation system used in physical medicine. It is designed to assess muscle strength and performance through controlled velocity movements.

This device is supplied by Physio Systems, Inc. and is a Class II medical device with FDA 510(k) clearance. It is not specified as single-use or reusable, and no MRI safety information is provided. The device is authorized for use in physical medicine settings.

Other devices from Physio Systems, Inc.

Questions

AI-generated answers, 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.

  • What is the Discipline II RTD used for?

    The Discipline II RTD is an isokinetic testing and evaluation system designed to assess muscle strength and performance through controlled velocity movements in physical medicine settings.

  • Is the Discipline II RTD a single-use or reusable device?

    The device data does not specify whether the Discipline II RTD is single-use or reusable. This information should be confirmed with the manufacturer, Physio Systems, Inc., before use.

  • What is the regulatory status of the Discipline II RTD?

    The Discipline II RTD is a Class II medical device with FDA 510(k) clearance, specifically with K number K871557, and was cleared on August 26, 1987.

  • How is the Discipline II RTD supplied?

    The Discipline II RTD is supplied by Physio Systems, Inc. The device data does not provide specific details on packaging or supply configurations.