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Electro-Goniometer Diagnostic Device

by Chattanooga Group, Inc.

510(k) K901290

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 NumberK901290 Date1 Oct 1990ClearedStatusActive

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  • Withdrawn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
LBB
Device Class
Class II
Regulation
21 CFR Part 888.1240
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Electro-Goniometer Diagnostic Device is a dynamometer, ac-powered device used for orthopedic applications. It measures joint angles and movement to assess musculoskeletal function and range of motion.

This device is supplied as a Class II medical device with FDA 510(k) clearance K901290, received on March 20, 1990, and deemed substantially equivalent on October 1, 1990. It is regulated under number 888.1240 and is not MRI safe. The device is available in various sizes and models as specified by the manufacturer.

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Questions

AI-generated answers, 21 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 Electro-Goniometer Diagnostic Device used for?

    The Electro-Goniometer Diagnostic Device is a dynamometer used for orthopedic applications to measure joint angles and movement, helping to assess musculoskeletal function and range of motion.

  • Is the Electro-Goniometer Diagnostic Device single-use or reusable?

    The device is not specified as single-use or reusable in the provided information. It is supplied as a Class II medical device with FDA 510(k) clearance, but its usage instructions regarding single-use or reuse are not detailed in the description.

  • What sizes and models are available for the Electro-Goniometer Diagnostic Device?

    The device is available in various sizes and models as specified by the manufacturer, Chattanooga Group, Inc. However, the specific sizes and models are not detailed in the provided information.

  • What is the regulatory status of the Electro-Goniometer Diagnostic Device?

    The Electro-Goniometer Diagnostic Device has FDA 510(k) clearance K901290, received on March 20, 1990, and was deemed substantially equivalent on October 1, 1990. It is regulated under number 888.1240 as a Class II medical device.