DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)

K972528 · Dyna Corp. · FPO · Jul 28, 1997 · General Hospital

Device Facts

• Record ID: K972528
• Device Name: DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
• Applicant: Dyna Corp.
• Product Code: FPO · General Hospital
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6910
• Device Class: Class 2

Indications for 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 Story

Dyna Glide 2600 is a roll-in ambulance cot designed for patient transport. Operated by trained Emergency Medical Technicians (EMT) or attendants in emergency medical settings. Device facilitates movement of patients into and out of ambulance patient compartments. Mechanical design eases physical burden of patient handling during emergency response. Benefits include improved efficiency and safety during patient transfer.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical patient handling device; roll-in ambulance cot configuration; designed for manual operation by EMTs; no electronic or software components.

Indications for Use

Indicated for patient transport in emergency medical situations. Intended for use by qualified and trained Emergency Medical Technicians (EMT)/Attendants for moving patients into and out of ambulance compartments.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Henry C. Perry ·Vice President Dyna Corporation 6300 Yarrow Drive Carlsbad, California 92009-1597

JUL 28 1997

Re : K972528 Dyna Glide 2600 Roll-In Ambulance Cot Trade Name: (95759) Requlatory Class: II Product Code: FPO Dated: July 1, 1997 Received: July 7, 1997

Dear Mr. Perry:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 \

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Page 2 - Mr. Perry

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification . The FDA ... . finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Clus L/sm
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Unknown 510(k) Number (if known):

Device Name: DYNA GLIDE 2600 ROLL-IN AMBULANCE COT

Indications For 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)alt Cucenti
Division of Dental, Infection Control,
and General Hospital Devic972538
510(k) NumberK972538

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

e-Counter Use **_**

(Optional Format 1-2-96)