BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000

K033438 · Bruno Independent Living Aids, Inc. · ILK · Nov 20, 2003 · Physical Medicine

Device Facts

• Record ID: K033438
• Device Name: BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
• Applicant: Bruno Independent Living Aids, Inc.
• Product Code: ILK · Physical Medicine
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

Device Story

Bruno Electra-Ride™ Elite Stairway Elevator System (Model SRE-2000) is a motorized stairway chairlift. Device assists mobility-impaired patients or individuals with limited physical capacity in navigating stairs. System consists of a chair mounted to a rail system installed on a staircase; powered by an electric motor. Operated by the patient or a caregiver via integrated controls. Provides safe, controlled vertical transport between floor levels. Benefits include increased patient independence and reduced physical strain on caregivers during transfers.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized stairway chairlift; rail-mounted seat system; electric motor drive; intended for residential or clinical use; mechanical transport mechanism.

Indications for Use

Indicated for patients or mobility-impaired persons requiring assistance for transport up and down flights of stairs.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Mr. Richard A. Keller Product Development Manager Bruno Independent Living Aids, Inc. 1780 Executive Drive P.O. Box 84 Oconomowoc, Wisconsin 53066

Re: K033438

Trade/Device Name: Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000 Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: October 1, 2003 Received: October 28, 2003

Dear Mr. Keller:

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. Richard A. Keller

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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,

Celia M. Witten, Ph.D., MD

elia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2 Indications for Use Statement

510(k) Number (if known):

Device Name: Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000

## Indications for Use:

The Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

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)

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Division

Division of General, Restorative and Neurological General, Rest

510(k) Number k 633436