NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES by BROMAC ASSISTIVE TECHNOLOGY

These wheelchairs have been designed as general purpose utility wheelchairs, to be used in, and for, the user's day to day living and transportation. They function as any standard power wheelchair does, however they are also designed to allow the user to easily and temporarily elevate the seating system to raise the user to a height slightly greater than that of an average person standing, or any height in between, allowing the user access to high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.

Device Description

New Heights Electric Electric Elevating Power Wheelchair Model No. 08 02 series

AI/ML Overview

I'm sorry, but this document is a 510(k) premarket notification letter from the FDA regarding a "New Heights Electric Elevating Power Wheelchair Model No. 08 02 series". It primarily discusses the substantial equivalence determination and regulatory compliance for this medical device.

The document does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML medical devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The information requested typically pertains to the rigorous evaluation of AI/ML-driven devices, which is not what this document addresses.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2002 JUL

Mr. David K. Brown Bromac Assistive Technology 15845 Sweetaire Avenue Lancaster, CA 93535

Re: K021165

Trade/Device Name: New Heights Electric Electric Elevating Power Wheelchair Model No. 08 02 series Regulation Number: 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: April 22, 2002 Received: May 7, 2002

Dear Mr. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David K. Brown

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

A. Stypte Rhodes

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

Enclosure

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K021165/

510(k) Number (if known): K021165

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative and Neurological Devices

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Prescription Use (Per 21 CFR 801-109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).