UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)

K973418 · Assembly Required Dist., Inc. · IOR · Oct 9, 1997 · Physical Medicine

Device Facts

• Record ID: K973418
• Device Name: UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
• Applicant: Assembly Required Dist., Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.

Device Story

Manual transport wheelchair; foldable design; chrome-plated finish; 8" front swivel casters; 24" rear mag-style wheels; padded or plastic armrests; padded embossed upholstery; non-slip vinyl push handles; rear anti-tip extensions; available with swing-away footrests or elevating legrests. Used in clinical or home environments to transport seated individuals; operated by user or assistant. Wheel locks provided for safety during patient transfer. Device provides mobility assistance for patients unable to ambulate independently.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Manual wheelchair; chrome-plated frame; vinyl push handles; padded/plastic armrests; 8" front swivel casters; 24" rear mag-style wheels; foldable form factor; mechanical wheel locks; rear anti-tip extensions.

Indications for Use

Indicated for individuals requiring a manual transport device to maneuver in a safe, controlled environment, allowing for self-propulsion or assistance by a caregiver.

Regulatory Classification

Identification

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Everest & Jennings model Universal wheelchair (K930411)
• Invacare model Rolls 2000 wheelchair (K881762)

Submission Summary (Full Text)

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## Assembly Required Distributors Inc.

3 Crabapple Lane Commack, NY 11725-2405 Phone/fax [phone]

14973418
September

September 5, 1997

## 510K Summary

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| Submitter: | Assembly Required Distributors Inc.<br>3 Crabapple Lane<br>Commack, NY 11725<br>516-864-9575 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Doreen Murphy |
| Date of Preparation: | 9/8/97 |
| Trade/Proprietary Name: | Transport Plus and Transport Deluxe |
| Common/Usual Name: | Manually Propelled Transport Wheelchair |
| Legally Marketed Device:<br>For Equivalence | Everest & Jennings model Universal wheelchair – K930411<br>Invacare model Rolls 2000 wheelchair - K881762 |
| Device Description: | Wheelchair to be a manual transport device, with 8" fron<br>swivel casters on the front, and 24" mag style wheels on the<br>rear. Wheelchair will be foldable for storage, will be chrom-<br>plate Finnish. Armrests will be padded or plastic and wil<br>have padded embossed upholstery for user comfort.<br>Wheelchair will be equipped with wheel locks to prevent<br>rolling while transferring patient. Push handles will be of a<br>non-slip vinyl material. Standard color available will be dark<br>blue. Chairs to have rear extensions to prevent tip-over.<br>Wheelchairs to be available in models with swing away<br>footrests or elevating legrests as shown in pictures. |
| Intended Use: | Predicate manual wheelchair use is stated to allow user, or<br>user assistant to propel or push chair in order to maneuver<br>seated individual in a safe, controlled environment. Also<br>must be able to lock rear wheels for patient transfer. Subject<br>wheelchair is to have same functionality. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping lines that suggest a face and neck. The figure is oriented to the right. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 1997

Ms. Doreen Murphy Compliance Officer Assembly Required Distributors, Inc. 3 Crabapple Lane Commack, New York 11725-2405

K973418 Re: Transport Plus and Transport Deluxe Trade Name: Requlatory Class: I Product Code: IOR September 8, 1997 Dated: Received: September 10, 1997

Dear Ms. Murphy:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Doreen Murphy

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 ene regaracion enereroa, "hibbianany "}} 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,

Celia M. Witten, Ph.D., M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Assembly Required Distributors Inc.

3 Crabapple Lane Commack, NY 11725-2405 Phone/fax [phone]

K973418

September 5, 1997

Intended Use:

Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.

Acoello

Over-the-Counter Use X