True-Trac Stratus

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K926316 ↗

FDA Product Code

JFB

Device Class

Class II

Regulation

21 CFR Part 890.5880

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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• Endomed CV405

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• What is the True-Trac Stratus designed for?

  The True-Trac Stratus is a multi-function table specifically engineered for physical therapy applications in physical medicine. It supports and facilitates therapeutic interventions, including exercises and treatments that require precise, adjustable positioning and stability. This design ensures clinicians can safely and effectively position patients for various rehabilitation needs.

• Is the True-Trac Stratus intended for single-use or reuse?

  The True-Trac Stratus is supplied as a reusable medical instrument. Unlike single-use devices, it is built for repeated use in clinical settings, provided it is properly cleaned and maintained between uses. This aligns with its classification as a Class II device under FDA regulations.

• What regulatory approval does the True-Trac Stratus hold?

  The True-Trac Stratus holds FDA 510(k) clearance under the reference number K926316. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for physical therapy tables in the United States. The product is classified under FDA’s product code JFB.

• Does the True-Trac Stratus have any specific safety considerations for use?

  The available data does not mention MRI safety or sterility requirements for the True-Trac Stratus. Clinicians should ensure the table is used in environments where its intended adjustable positioning and stability features are compatible with the clinical setting. Proper maintenance and adherence to manufacturer guidelines are essential for safe and effective use.

• What are the key features that distinguish the True-Trac Stratus?

  The True-Trac Stratus is distinguished by its multi-function design, tailored for adjustable positioning and stability in physical therapy. This includes features that support a range of therapeutic interventions, making it versatile for various rehabilitation exercises. Its reusable nature and FDA clearance further emphasize its reliability for clinical use.