The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices. The models to be offered are of different sizes allowing for user preferance because of physical needs. Options for users include removeable armrests & detachable footrests to accomodate user requirements.

AI/ML Overview

This document is a 510(k) premarket notification for a mechanical folding wheelchair, submitted to the FDA in 1997. It is not a study report that describes acceptance criteria and device performance in the way a medical device efficacy study would.

Therefore, I cannot extract the information required in your request from the provided text for the following reasons:

No Acceptance Criteria or Performance Data: The document states the device is "substantially equivalent" to existing products, but it does not define specific acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or technical benchmarks) or report performance metrics (e.g., a study showing how well the device performs against these criteria). The provided tables are for dimensions and weights of various models, not performance data against specific criteria.
No Study Conducted (in this context): A 510(k) notification primarily argues for substantial equivalence to a predicate device. It typically doesn't involve new clinical trials or rigorous performance studies to establish "acceptance criteria" and "prove the device meets them" in the way a novel medical diagnostic or therapeutic device would. The core of a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
No Details on Specific Study Design: Since no specific performance study against defined acceptance criteria is presented, there is no information about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

In summary, the provided text is a regulatory submission for a medical device (a wheelchair), arguing for its substantial equivalence to already marketed devices. It does not contain the kind of performance study data and acceptance criteria you would find for a diagnostic or AI-driven device.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for "HEARTWAY". The logo consists of the word "HEARTWAY" in bold, sans-serif font, with a stylized graphic above it. The graphic is composed of several horizontal lines that are arranged in a semi-circular or arched shape, resembling a series of stacked, curved bars. The overall design is simple and bold, with a focus on the text and the geometric shape above it.

HEARTWAY MEDICAL PRODUCTS CO

NO. 4, ROAD 5, TAICHUNG INDUSTRIAL PARK, HUNG. TAIWAN FI. O. C 80357 (Sales Den

DEC - 4 1997

Internet: http://www.webtree.net.tw/heartway/ E-mail: heartway@webtree.net.tw

K973491

Office of Device Evaluation 510(k) Document Mail Center (HFZ-401) Food & Drug Administration 1390 Piccard Drive Rockville, Maryland 20850

Dear Sir or Madam,

In accordance with the requirements of section 510(k) of the Federal Food and Drug Cosmetic Act we hereby request to register for commercial distribution for the following device.

	Device Name ------------------------------------------------------------------------------------------------------------------------------------------------------------------
Common Name ------------------------------------------------------------------------------------------------------------------------------------------------------------------
	Heartway Models---------------------------------------------------------------------------------------------------------------------------------------------------------------
Proprietary Name -------------------------------------------------------------------------------------------------------------------------------------------------------------
Established Registration No. ------------------------------------------903564
FDA Classification -----------------------------------------------------------------------------------------------------------------------------------------------------------

Summary

The wheelchairs listed above are substantially equivalent to many products being Marketed at this time. Wheelchairs of this type compare with the Invacare Tracer Plus Series (See Exhibit II) and the Everest & Jennings Traveler Series (see Exhibit III)

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New Traveler

Image /page/1/Picture/1 description: The image shows a close-up of a wheelchair. The wheelchair is black and silver. The wheels are large and have a silver rim. The seat is not visible in the image.

TRAVELER QUALITY AND DURABILITY. . . Ever evolving to meet the needs of our customers, the "New" Traveler enhances its reputation as the rental wheelchair of choice. Now available with dual rear axle positioning for seat heights from 17-3/4" to 19-3/4", seat widths from 16" to 22" wide and a weight capacity of up to 300 pounds. The Traveler has earned its reputation for enduring the rigors of all types of use. . . designed to survive the journey.

· Dual axle positioning ... seat heights between 17-3/4" and 19-3/4".
· Front slide post design provides added rigidity and easy folding.
· Reinforced top inner rail for extra strength.
· Strong upholstery inner liner tested at 350 lbs. per inch, lasts twice as long as comparable models.
· Low-maintenance, reinforced molded wheels with snap-on solid tires.
· Desk length or full length arms available for easy transfer and access.
· Superior E&J cam-action footrest design combined with quality manufacturing provide a snug fit and a true swing-away motion.
· 300 lb. capacity on 20" and 22" wide models.
· 2 year limited warranty on frame and crossbraces.

Image /page/1/Picture/12 description: The image shows the logo for Everest Jennings. The text "Everest Jennings" is in a bold, serif font. Below the company name is the tagline "Value through Innovation" in a smaller, italicized font. The logo is simple and professional.

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TM

Image /page/2/Picture/1 description: The image is a black and white photograph of a metal structure. The structure appears to be a framework of some kind, with vertical and diagonal beams. The beams are connected by smaller pieces of metal. The image is dark and grainy, and the structure is not clearly defined.

DUAL AXLE BUSHINGS

Allows for easy seat conversion of seat heights from 17-3/4" to 19-3/4" through use of different wheels and caster combinations.

FEATURES

·Padded, double-embossed burgundy leatherette upholstery and padded armrests.
•Durable 24" x 1" black molded wheel with snapon rubber tire.
•8″ x 1″ black molded front casters.
· Rugged cam-action swing-away detachable footrests or elevating legrests.
•Durable aluminum footplate.
·Choice of 3 frame styles: std. fixed arm, Std/Hemi/Extra wide detachable arm and Std/Hemi recliners.
· Available with a variety of optional arm styles.

All specifications subject to change without notice.

"New" Traveler™ Dimensions and Weights (inches and pounds)

"New" TravelerModels	SEAT		ARMS		BACK	OVERALL			EXTENSIONS				WT.
									FOOTRESTS		LEGRESTS		LBS.
Fixed Arm, Narrow Adult	16	16	$141/4$	$101/8$	$161/2$	30	36	$221/2$	$11$	$161/2$	22	16	23	35
Fixed Arm, Adult	18	16	$161/4$	$101/8$	$161/2$	30	36	$241/2$	$11$	$161/2$	22	16	23	36
Detachable Arm,Narrow Adult, Hemi	15	16	$173/4$	$93/4$	$161/2$	30	36	$241/4$	$11$	$161/2$	20	16	23	40
Detachable Arm, Adult, Hemi	18	16	$173/4$	$93/4$	$161/2$	30	36	$261/4$	$11$	$161/2$	20	16	23	41
Detachable Arm, Narrow Adult	16	16	$193/4$	$93/4$	$161/2$	30	36	$241/4$	$11$	$161/2$	22	16	23	40
Detachable Arm, Adult	18	16	$193/4$	$93/4$	$161/2$	30	36	$261/4$	$11$	$161/2$	22	16	23	41
Detachable ArmNarrow Adult Recliner	16	17	$193/4$	$93/4$	$233/8$	36	$531/8$	$241/4$	13	$161/2$	22	15	21	55
Detachable Arm, Adult Recliner	18	17	$193/4$	$93/4$	$233/8$	36	$531/8$	$261/4$	13	$161/2$	22	15	21	55
Detachable ArmAdult-Wide (20")	20	16	$193/4$	$93/4$	$161/2$	30	36	$281/4$	$113/4$	$161/2$	22	16	23	47
Detachable ArmAdult-Extra Wide (22")	22	16	$193/4$	$93/4$	$161/2$	30	36	$301/4$	$113/4$	$161/2$	22	16	23	48

"Without front rigging. All dimensions are + or - 1/4"

NOTE: Everest & Jennings maintains the policy of continual product improvement, therefore we reserve the right to make changes without notice.

Everest & Jennings®

Value through Innovation

United States 4203 Earth City Exprswy St. Louis, MO 63045

203 Earth City Exprswy
St. Louis, MO 63045

For additional information call 1-800-235-4661 Canada LAK 218 For additional information call

1-905-669-2381

111 Snidecroft Road

Concord, Ontario,

Canada

Mexico Calle 3 No. 631 Zona Industrial Codigo Postal 44940 Guadalajara, Jalisco Mexico

For additional information call (011) 52-36-12-12-34

PN# 02003023 7/96 Printed in the USA

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 1997

Mr. Kenny Ho ·President Heartway Medical Products Company, Limited Number 4, Road 5, Taichung Industrial Park Taichung, Taiwan R.O.C.

K973491 Re: Mechanical Folding Wheelchair Requlatory Class: I Product Code: IOR Dated: October 27, 1997 -October 31, 1997 Received:

Dear Mr. Ho:

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 Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 regulations.

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Page 2 - Mr. Kenny Ho

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Whitten, Ph.D.

ia 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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Page of

510(k) Number (if known): K973491

STANDARD FOLDING WHEELCHAIR Device Name:

Indications For Use:

The models to be offered are of different sizes allowing for user preferance because of physical needs. Options for users include removeable armrests & detachable footrests to accomodate user requirements.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

to see

Division of General Restorative Dev 510(k) Number

Prescription Use ._ (Per 21 CFR 801 109)

Over-the-Counter Use. \

(Optional Format 1-2-96)

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
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.(b)
Classification. Class I (general controls).