FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

Device Name

Manufacturer

CARDIO SYSTEMS, INC.

Date Cleared

1998-01-22

(234 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

FOR The PREVENTION AND TREAT M [sic] PRESSURE ULCERS OF [sic]

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ZAK-2000" for the prevention and treatment of pressure ulcers. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request based on the given input.

Summary

Regulation Number and Section

§ 880.5550 Alternating pressure air flotation mattress.

(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.