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Universal-Ergotest

by Erich Jaeger, Inc. 510(k)

Active United States

510(k) K843850

Overview

The Universal-Ergotest is a device classified as an Exerciser, Measuring, designed to assess muscle strength and endurance in physical medicine applications. It provides quantitative measurements of ergometric performance, typically used to evaluate the functional capacity of limbs or core musculature during controlled resistance exercises.

This device is supplied as a reusable medical instrument, intended for use in clinical or rehabilitation settings. It is not sterile and requires cleaning and maintenance between uses. The Universal-Ergotest is regulated under FDA 510(k) clearance (K843850) and falls under the product code ISD, with no specified MRI safety restrictions. No additional regulatory authorisations beyond the FDA clearance are stated.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843850 Date27 Nov 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ISD
Device Class
Class II
Regulation
21 CFR Part 890.5360
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Universal-Ergotest used for?

    The Universal-Ergotest is designed as an Exerciser, Measuring device to assess muscle strength and endurance. It quantifies ergometric performance during controlled resistance exercises, helping clinicians evaluate the functional capacity of limbs or core musculature in physical medicine and rehabilitation settings.

  • Is the Universal-Ergotest reusable or single-use?

    The Universal-Ergotest is a reusable medical instrument. It is intended for repeated use in clinical or rehabilitation environments but requires thorough cleaning and maintenance between uses to ensure accuracy and hygiene.

  • Does the Universal-Ergotest come sterile?

    No, the Universal-Ergotest is not supplied sterile. It is intended for non-sterile clinical applications, and proper cleaning protocols must be followed to maintain its functionality and prevent cross-contamination.

  • What regulatory approval does the Universal-Ergotest hold?

    The Universal-Ergotest holds FDA 510(k) clearance under the product code ISD, with a decision of Substantially Equivalent in the Physical Medicine advisory committee category. The clearance number is K843850, and it was originally received in 1984.

  • Are there any MRI safety restrictions for the Universal-Ergotest?

    The device data does not specify any MRI safety restrictions for the Universal-Ergotest, meaning it may be used in environments where MRI procedures are performed, though users should always verify compatibility with their specific MRI system.