DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)

• K Number: K972528
• Device Name: DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
• Manufacturer: DYNA CORP.
• Date Cleared: 1997-07-28 ( 21 days)
• Product Code: FPO
• Regulation Number: 880.6910
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The Dyna GLIDE 2600 Roll-in Ambulance Cot is a PROFESSIONAL USE ONLY patient handling device with designed features allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose of the Dyna GLIDE 2600 is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Dyna GLIDE 2600 Roll-In Ambulance Cot." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study design, or performance data of the device itself.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria, as it is not present in the given text.

The information I can extract from the document is related to the device's regulatory approval:

• Device Name: Dyna GLIDE 2600 Roll-In Ambulance Cot
• Intended Use: A PROFESSIONAL USE ONLY patient handling device with designed features allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.
• Regulatory Class: II
• Premarket Notification Number: K972528 (though it is K972538 at the bottom of page 2)
• Approval Date: July 28, 1997

Regulation Number and Section

§ 880.6910 Wheeled stretcher.

(a)
Identification. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.(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.