Unit-Matt 5000 Pressure Relief System
by United Medical Equipment, Inc.
510(k) K962585
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962585 | Date7 Jan 1997 | 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- Withdrawn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
- FNM
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5550
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Unit-Matt 5000 Pressure Relief System is a mattress, air flotation, alternating pressure device intended for general hospital use. It is designed to provide pressure relief through alternating air flotation technology to help prevent pressure ulcers.
The device is supplied as a reusable system and has received FDA 510(k) clearance under K962585. It is classified as a Class II medical device under regulation number 880.5550 and is manufactured by United Medical Equipment, Inc. No information regarding sterility, MRI safety, specific sizes, or storage conditions is provided in the data.
Questions
AI-generated answers, 23 Sep 2026
What is the Unit-Matt 5000 Pressure Relief System intended for?
The Unit-Matt 5000 Pressure Relief System is intended for general hospital use to provide pressure relief through alternating air flotation technology, helping to prevent pressure ulcers by redistributing pressure across the patient's body.
Is the Unit-Matt 5000 Pressure Relief System reusable or single-use?
The Unit-Matt 5000 Pressure Relief System is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance between patients, as indicated in the device description.
What regulatory clearance does the Unit-Matt 5000 Pressure Relief System have?
The Unit-Matt 5000 Pressure Relief System has received FDA 510(k) clearance under submission number K962585, which confirms it is substantially equivalent to a legally marketed predicate device for its intended use.