NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

K012345 · Bromac Assistive Technology · IPL · Oct 3, 2001 · Physical Medicine

Device Facts

• Record ID: K012345
• Device Name: NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
• Applicant: Bromac Assistive Technology
• Product Code: IPL · Physical Medicine
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2

Intended Use

This wheelchair is designed as a general purpose utility wheelchair, to be used in, and for, the users day to day living and transportation. It functions as any standard manual wheelchair does, however it is 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 able bodied person standing, or any height in between, allowing the user to access high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.

Device Story

New Heights Electric Elevating Manual Wheelchair functions as a standard manual wheelchair for daily mobility; includes an electric elevating mechanism allowing users to raise the seat to standing-equivalent heights. Operated by the user to access high shelves or cabinets. Benefits include increased independence and accessibility in home or community environments. Device provides mechanical elevation of the seating system; no complex software or AI algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric elevating manual wheelchair; class II device (890.3900); product code IPL. Features manual mobility base with integrated electric actuator for seat elevation. No software or complex algorithms.

Indications for Use

Indicated for individuals requiring a manual wheelchair for daily living and transportation who desire the ability to temporarily elevate the seating system to reach heights above a standard seated position.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2001

David K. Brown Bromac Assistive Technology 15845 Sweetaire Avenue Lancaster. California 93535

Re: K012345

Trade/Device Name: New Heights Electric Elevating Manual Wheelchair Regulation Number: 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: August 23, 2001 Received: September 18, 2001

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 - 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 promated predicated 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 [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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

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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K012345 510(k) Number (if known):

Electric Elevating Manual Wheelchair Device Name:

Indications For Use:

This wheelchair is designed as a general purpose utility wheelchair, to be used in, and for, the users day to day living and transportation. It functions as any standard manual wheelchair does, however it is 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 able bodied person standing, or any height in between, allowing the user to access high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

fo Mark N Miller

f General, Restorative and Now ological Devices

510(k) Number