Bio-Coordinator System
510(k) K895398
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895398 | Date28 Sep 1989 | 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- Withdrawn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
- IKK
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1925
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Bio-Coordinator System is an Isokinetic Testing and Evaluation System (Product Code IKK), designed for physical medicine applications. It is a rehabilitative exercise device intended to measure, evaluate, and assess muscle strength and joint range of motion through controlled, variable-resistance movements. This system facilitates objective performance analysis, aiding in the development of targeted rehabilitation protocols for patients.
The device is supplied as a reusable medical instrument, intended for use in clinical settings such as physical therapy or rehabilitation centers. It operates under FDA 510(k) clearance (K895398) and falls under Regulation 890.1925, classified as a Class II device. No third-party certification or additional sterility requirements are specified, and its use does not involve MRI compatibility constraints. The system is regulated under the Physical Medicine advisory committee and is intended for professional medical use only.
Questions
AI-generated answers, 20 Sep 2026
What types of clinical settings is the Bio-Coordinator System intended for, and how does it support rehabilitation efforts?
The Bio-Coordinator System is designed for clinical settings like physical therapy or rehabilitation centers. It measures muscle strength and joint range of motion through controlled, variable-resistance movements, enabling objective performance analysis. This data helps clinicians develop targeted rehabilitation protocols tailored to individual patient needs, improving the precision of recovery plans.
Is the Bio-Coordinator System reusable, and if so, what maintenance considerations should be taken into account?
Yes, the Bio-Coordinator System is supplied as a reusable medical instrument. Since it is not classified as single-use, proper cleaning and maintenance protocols must be followed to ensure hygiene and longevity. The manufacturer’s guidelines should be consulted for specific care instructions, though no third-party sterility requirements are specified for this device.
What regulatory pathway was followed for the Bio-Coordinator System, and how does this affect its use?
The Bio-Coordinator System was cleared through the FDA’s 510(k) process (K895398) under the Physical Medicine advisory committee, classified as a Class II device. This means it has been deemed substantially equivalent to a legally marketed predicate device and is regulated under Regulation 890.1925. Its use is restricted to professional medical settings, adhering to FDA guidelines for isokinetic testing and evaluation systems.
Does the Bio-Coordinator System require any special storage conditions, and can it be used in environments with MRI equipment?
The device does not have documented special storage requirements beyond standard operating conditions for medical equipment. Additionally, its use is not constrained by MRI compatibility, meaning it can be safely used in facilities with MRI machines without interference or safety concerns.