Wright Model 51 and 52 Sequential Compression Systems
510(k) K071040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071040 | Date22 May 2007 | 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- Withdrawn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
- JOW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Wright Model 51 and 52 Sequential Compression Systems are pneumatic compression pumps used to treat lymphedema, venous insufficiencies, and edematous conditions. The device consists of a pump enclosure containing an air compressor, solenoid valves, and a microprocessor-controlled circuit board.
These systems are sequential, segmental, intermittent pneumatic compression pumps with appropriate limb appliances. They are supplied as non-sterile devices and are classified as Sleeve, Limb, Compressible under regulation 870.5800 with FDA 510K clearance K071040.
Other devices from Wright Linear Pump, Inc.
Questions
AI-generated answers, 28 Sep 2026
What clinical conditions are the Wright Model 51 and 52 designed to treat?
They are intended for patients with lymphedema, venous insufficiencies, and other edematous conditions. The sequential, segmental compression promotes fluid movement and reduces swelling, which is why they are used in these specific vascular and lymphatic disorders.
How are the devices supplied and what is their sterility status?
Both models are provided as complete, non‑sterile systems that include the pump enclosure, air compressor, solenoid valves, microprocessor board, and appropriate limb appliances. Because they are non‑sterile, they are intended for external use on intact skin rather than invasive procedures.
Are the Wright Model 51 and 52 single‑use or reusable devices?
The systems are reusable. The pneumatic pump and electronic components are designed for repeated clinical use, while the limb sleeves or garments that contact the patient may be replaced or cleaned according to the manufacturer’s instructions.
What regulatory classification applies to these compression systems?
They are classified under regulation 870.5800 as a Sleeve, Limb, Compressible device and received FDA 510(k) clearance (K071040) as a traditional, substantially equivalent Class II device.