OrthoTrak
510(k) K890076
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890076 | Date3 Feb 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LXJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5360
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The OrthoTrak is an Interactive Rehabilitation Exercise Device, designed for assessing and documenting joint range of motion, muscle strength, and functional movement patterns in physical medicine settings. It integrates with motion analysis systems to provide quantitative measurements of patient performance, aiding in rehabilitation planning and progress tracking. The device is classified as a Class II medical device under FDA regulations, requiring premarket notification (510(k)) clearance for commercial distribution.
OrthoTrak is supplied as a standalone system, intended for use in clinical or research environments by trained professionals such as physical therapists or rehabilitation specialists. The device is not described as single-use or sterile, and its regulatory submission (K890076) references traditional 510(k) clearance under the Interactive Rehabilitation Exercise Devices product code (LXJ). No MRI safety or sterility requirements are specified in the available data. Storage and handling instructions are not provided in the regulatory records, but the device is associated with multiple registration numbers under the Physical Medicine specialty.
Other devices from Motion Analysis Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the OrthoTrak used for in physical therapy settings?
The OrthoTrak is designed to assess and document joint range of motion, muscle strength, and functional movement patterns during rehabilitation. By integrating with motion analysis systems, it provides quantitative measurements that help clinicians evaluate patient performance, tailor treatment plans, and monitor progress over time. This data-driven approach supports evidence-based decision-making in physical medicine.
How is the OrthoTrak supplied and intended for use?
The OrthoTrak is supplied as a standalone system, intended exclusively for clinical or research environments. It is operated by trained professionals such as physical therapists or rehabilitation specialists. The device is not intended for home use or single-patient procedures, and its use requires familiarity with motion analysis systems to interpret the quantitative data it generates.
Is the OrthoTrak sterile or single-use?
The OrthoTrak is not described as sterile or single-use in available regulatory records. It is intended for repeated use in controlled clinical settings, where proper cleaning and maintenance protocols should be followed to ensure accuracy and hygiene. No specific sterility requirements or single-use limitations are mentioned in the documentation.
What regulatory pathway does the OrthoTrak follow?
The OrthoTrak is classified as a Class II medical device under FDA regulations and has undergone a traditional 510(k) clearance process. This pathway requires premarket notification to demonstrate substantial equivalence to a predicate device. The device’s clearance (K890076) falls under the Interactive Rehabilitation Exercise Devices product code (LXJ), with the Physical Medicine advisory committee overseeing its review.
Are there specific storage or handling instructions for the OrthoTrak?
The regulatory records do not provide explicit storage or handling instructions for the OrthoTrak. However, as a reusable clinical device, it should be stored in a clean, dry environment protected from physical damage or environmental contaminants. Users should follow manufacturer guidelines (available in the device’s documentation) to maintain calibration and functionality, though no MRI safety or sterility requirements are specified.