Electro-Goniometer Diagnostic Device
510(k) K901290
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901290 | Date1 Oct 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Chattanooga Group, Inc.
Questions
AI-generated answers, 21 Sep 2026
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.