AmySystems PTS50CG 50 Degree Weight Shift Power Tilt System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994072 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AmySystems PTS50CG 50 Degree Weight Shift Power Tilt System is a Powered Wheelchair Tilt System designed to provide controlled posterior tilting for seated users. It adjusts the seat angle to redistribute weight and pressure, aiding in patient positioning and reducing the risk of pressure ulcers. This system is classified as a Class II medical device under FDA regulation 890.3860, intended for integration with powered wheelchairs as either an add-on or integrated component.
The system is single-use or reusable depending on manufacturer specifications and is intended for use in clinical settings such as physical medicine rehabilitation. It operates via manual or caregiver control to achieve a 50-degree tilt range, ensuring adjustable pressure relief. The device holds FDA 510(k) clearance (K994072) under the Physical Medicine advisory committee, with a Traditional 510(k) review and Substantially Equivalent (SESE) determination. No MRI safety or sterility specifications are provided in the regulatory data.
Frequently asked questions
What is the primary purpose of the AMYSYSTEMS PTS50CG 50 Degree Weight Shift Power Tilt System, and how does it benefit users?
The AMYSYSTEMS PTS50CG is designed to provide controlled posterior tilting for seated users in powered wheelchairs. It adjusts the seat angle to redistribute weight and pressure, which helps improve patient positioning and reduces the risk of pressure ulcers—commonly seen in prolonged seating scenarios. This system is intended for clinical use in physical medicine rehabilitation settings.
Is the AMYSYSTEMS PTS50CG meant to be used as a standalone device, or does it require integration with another system?
The PTS50CG is specifically designed as an add-on or integrated component for powered wheelchairs. It is not intended for standalone use but rather to enhance existing wheelchair systems by providing adjustable tilt functionality for pressure relief.
How is the AMYSYSTEMS PTS50CG controlled, and who typically operates it?
The system is operated via manual or caregiver control, allowing for adjustable pressure relief through a 50-degree tilt range. This design ensures flexibility in use, accommodating both self-propelled and assisted wheelchair environments.
What regulatory pathway was followed for FDA clearance of the AMYSYSTEMS PTS50CG, and what does this mean for its use?
The device received FDA clearance through a Traditional 510(k) review process, determined to be Substantially Equivalent (SESE) under the Physical Medicine advisory committee. This clearance indicates it meets FDA standards for safety and effectiveness as a Class II medical device, specifically for integration with powered wheelchairs.
Is the AMYSYSTEMS PTS50CG reusable, or is it intended for single-use only?
The device’s reuse or single-use status depends on manufacturer specifications, which are not detailed in the provided regulatory data. Clinicians should refer to the manufacturer’s instructions for proper usage guidelines, as this can impact maintenance, cleaning, and replacement protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Amysystems Pts50cg 50 Degree Weight Shift Power Tilt System, K994072 - Amysystems Pts50cg 50 Degree Weight Shift Power Tilt System, AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994072 | Class II | Active |
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Manufacturer
- Manufacturer
- Amylior, Inc.
Sources (1)
- FDA 510(k) K994072 24 fields · synced Sep 19, 2026