Phoenix Powered Exoskeleton

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Phoenix

510(k) Number

K183152 ↗

FDA Product Code

PHL

Device Class

Class II

Regulation

21 CFR Part 890.3480

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• What types of mobility impairments is the Phoenix designed to assist with, and how does it work?

  The Phoenix is a powered exoskeleton designed to assist individuals with mobility impairments by providing external mechanical support to enhance walking, standing, and movement. It uses motorised joints to offer functional independence, helping users regain or maintain mobility through robotic assistance. While it is classified under Physical Medicine, its specific clinical indications are not detailed beyond its role in aiding mobility for users with limitations.

• Is the Phoenix intended for single-use or reusable applications, and what does that mean for maintenance?

  The Phoenix is explicitly supplied as a reusable device for both clinical and home use. Since it is not sterile, maintenance and cleaning protocols will be required to ensure safe, repeated use across patients or users. The manufacturer’s instructions (not provided here) would outline proper care procedures to sustain functionality and hygiene.

• How do I determine if a Phoenix unit is compatible with my facility’s needs, given the multiple registration numbers listed?

  The Phoenix is associated with several registration numbers (e.g., 3015000676) under the product code PHL, which may correspond to variations in model specifications or configurations. These numbers reflect administrative filings rather than distinct clinical indications. To confirm compatibility, verify the specific model or variant you require with Us Bionics, Inc. (Dba Suitx), as the exact technical differences between registrations are not detailed in the provided data.

• What storage requirements should I consider for the Phoenix exoskeleton?

  Since the Phoenix is reusable and not sterile, storage should prioritise protection from physical damage, moisture, and contamination. The manufacturer’s guidelines (not provided here) would specify ideal conditions, such as temperature ranges or environmental controls, to preserve the device’s mechanical integrity and motorised components. Avoid exposure to direct sunlight or extreme temperatures.

• How can I verify the regulatory pathway and clearance status of the Phoenix before purchasing?

  The Phoenix was cleared via the Traditional 510(k) pathway (K183152) and classified as a Class 2 device under FDA regulation 890.3480 for Physical Medicine applications. To confirm its current status, you may reference the FDA’s OpenFDA database using the registration numbers (e.g., 3015000676) or contact Us Bionics, Inc. directly for the most up-to-date information, as regulatory filings can evolve.