Identifiers
- 510(k) Number
- K131387 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Wright Gradient 52 - Torso is a pneumatic compression device designed to treat lymphedema, venous insufficiencies, and other edematous conditions. It consists of a pneumatic compression pump, a hose assembly, and associated inflatable appliances that compress upper and lower body extremities and portions of the torso. The pump includes an enclosure with a small air compressor, solenoid valves, and a programmable microprocessor-controlled printed circuit board.
The device is supplied as a single-use or reusable system, depending on the configuration, and is intended for use in clinical settings. It is not specified as MRI-safe, and storage requirements are not detailed in the provided data. The device is regulated under FDA 510(k) clearance (K131387) and is classified as a Class II medical device.
Frequently asked questions
What is the Wright Gradient 52 Torso used for?
This device is a pneumatic compression system designed to treat lymphedema, venous insufficiencies, and other edematous conditions by applying pressure to the upper and lower body extremities and torso.
Is the Wright Gradient 52 Torso reusable?
The device is supplied as a single-use or reusable system, depending on the specific configuration purchased.
How is the Wright Gradient 52 Torso powered?
The device includes an enclosure with a small air compressor, solenoid valves, and a programmable microprocessor-controlled printed circuit board to generate and regulate the pneumatic compression.
What is the regulatory status of the Wright Gradient 52 Torso?
The Wright Gradient 52 Torso is regulated under FDA 510(k) clearance (K131387) and is classified as a Class II medical device.
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: WRIGHT GRADIENT 52 - TORSO by WRIGHT THERAPY PRODUCTS, INC | FDA 510(k ..., WRIGHT GRADIENT 52 - TORSO (K131387) — FDA 510(k) | Innolitics, K131387 FDA 510 (k) - WRIGHT GRADIENT 52 - TORSO, WRIGHT GRADIENT 52 - TORSO 510 (k) K131387 - 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 | K131387 | Class II | Active |
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Manufacturer
- Manufacturer
- Wright Therapy Products, Inc.
Sources (1)
- FDA 510(k) K131387 24 fields · synced Sep 26, 2026