BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM

K970927 · Bruno Independent Living Aids, Inc. · ILK · Aug 26, 1997 · Physical Medicine

Device Facts

• Record ID: K970927
• Device Name: BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
• Applicant: Bruno Independent Living Aids, Inc.
• Product Code: ILK · Physical Medicine
• Decision Date: Aug 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This Product will be used by the patient to assist themselves in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and / or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who can not handle the exertion of walking up and down the stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because it eases the burden of climbing the stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.

Device Story

Stairway elevator system; self-contained unit mounted to staircase treads. Assists patients with limited mobility in navigating stairs. Installed and tested by trained dealers; end-user training provided. Operated by patient. Reduces physical exertion required for stair climbing; improves quality of life for individuals with joint limitations or chronic conditions. Alternative for wheelchair users when vertical elevators are not feasible.

Clinical Evidence

No clinical data.

Technological Characteristics

Electromechanical stairway elevator system; tread-mounted; self-contained unit.

Indications for Use

Indicated for patients with limited knee, hip, or ankle function/joint mobility, including those with arthritis, MS, heart disease, or stroke recovery, and individuals unable to exert themselves walking on stairs. Requires ability to transfer for wheelchair-bound users.

Regulatory Classification

Identification

Powered patient stairway chair lifts: A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway. All other powered patient transport: A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.

Special Controls

(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure; (ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety; (iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”); (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and (v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 26 1997

Mr. William W. Belson III
Director of Engineering
Bruno Independent Living Aids
1780 Executive Drive
P.O. Box 84
Oconomowoc, Wisconsin 53066

Re: K970927
Bruno Electra-Ride™ III Stairway Elevator System
Regulatory Class: II
Product Code: ILK
Dated: July 19, 1997
Received: August 14, 1997

Dear Mr. Belson:

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, 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 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 action. In addition, FDA may publish further announcements 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 regulations.

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Page 2 - Mr. William W. Belson III

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 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,

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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510(k) Number (if known): K970927

Device Name: STAIRWAY ELEVATOR

Indications For Use:

This Product will be used by the patient to assist themselves in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and / or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who can not handle the exertion of walking up and down the stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because it eases the burden of climbing the stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☐ OR Over-The-Counter Use ☑

(Per 21 CFR 801.109)

(Optional Format 1-2-96)