STAIRFRIEND CURVED STAIRWAY CHAIRLIFT

K023852 · Services Industriels Savaria, Inc. · ILK · Mar 4, 2003 · Physical Medicine

Device Facts

• Record ID: K023852
• Device Name: STAIRFRIEND CURVED STAIRWAY CHAIRLIFT
• Applicant: Services Industriels Savaria, Inc.
• Product Code: ILK · Physical Medicine
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The product will be used by patients 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 cannot 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 to eases the burden of climbing 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

Stairfriend curved stairway chairlift; assists patients in navigating residential stairs. Input: user operation via wireless call-send controls or continuous pressure buttons. Operation: rack and pinion drive; 24 vdc battery-powered motor; electronic controller with soft start; dynamic motor braking; self-locking gearbox. Output: carriage movement along rigid double square tube rail. Safety features: obstruction sensors on footrest; seat swivel safety switch; carriage limit switches. Used in residential settings; installed by trained dealer; operated by patient. Benefits: eases stair climbing; improves quality of life for mobility-impaired individuals.

Clinical Evidence

No clinical data; bench testing only. Device design and engineering verified against CSA-B355 and ASME A17.1 safety standards.

Technological Characteristics

Rigid double square tube rail construction; rack and pinion drive; 24 vdc battery-powered motor; 110 vac charger; electronic controller with soft start; fused control circuit; wireless controls; obstacle sensors; seat swivel safety switch. Meets CSA-B355 and ASME A17.1 standards.

Indications for Use

Indicated for patients with limited knee, hip, or ankle function, joint bending difficulties, stroke recovery, MS, arthritis, heart disease, or general physical exertion limitations preventing stair navigation. 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.

Predicate Devices

• Bruno Electra-Ride III (K970927)

Submission Summary (Full Text)

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MAR 0 4 2003

:

| Submitted by: | Barnes, Richardson & Colburn<br>1225 Eye Street, N.W.<br>Washington, D.C. 20005 |
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| Contact: | Stephen Brophy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Tel: [phone] |
| Date Prepared: | November 1, 2002 |
| Subject Device: | "Stairfriend" Curved Stairway Chairlift                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          &nK023852 |
| Predicate Device: | .Bruno Electra-Ride III (510(k) number K970927) |
| Subject Product Description: | The Stairfriend is a curved stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence. The Stairfriend is designed to travel a maximum 30 feet at a rated speed of 16 feet per minute. Safety switches installed on the Stairfriend stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. Standard equipment includes: <ul><li>Rack and pinion drive</li><li>Dynamic motor braking and self-locking gearbox</li><li>2" (51 mm) rigid double square tube rail construction</li><li>Inside and outside radius curve capabilities</li><li>Spiral and flat landing configurations</li><li>Support posts anchored to stair treads (no wall required)</li><li>300 lb (136 kg) capacity</li><li>Battery-powered 24 vdc motor</li><li>Pair of 12-volt, maintenance-free batteries</li><li>Charger to be plugged in at top or bottom landing 110 vac, 15 amp, 60 hz outlet</li><li>Electronic controller with soft start</li><li>Fused control circuit</li><li>Wireless call-send controls at both landings</li><li>Continuous pressure buttons</li><li>No rail overhang at top landing</li><li>Foldable footrest, seat and padded armrest</li><li>Seat that swivels and locks in 60° and 90° positions in both directions</li><li>Seatbelt</li><li>Seat swivel safety switch</li><li>Obstacle sensor</li></ul> |

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| Intended Use: | The product will be used by patients 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 cannot 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 to eases the burden of climbing 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. |
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## Product Comparison:

The Stairfriend is substantially equivalent to the Bruno Electra-Ride III (K970927). Both products are used by patients to assist themselves in navigating a specific set of stairs. They are both self-contained product that are mounted to the tread of a staircase. Both stairlifts (Bruno and Savaria) have been designed and engineered to meet and exceed the safety standards CSA-B355 -- "Lifts for persons with physical disabilities" and ASME A17.1 part XX and part XXI "Safety Code for Elevators and Escalators".

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by a triple-stranded helix, resembling a stylized human figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Services Industriels Savaria, Inc. c/o Mr. Stephen Brophy Barnes, Richardson & Colburn 1225 Eye Street, N.W. Suite 1150 Washington, DC 20005

Re: K023852

Trade/Device Name: "Stairfriend" Curved Stairway Chairlift Regulation Number: 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: February 5, 2003 Received: February 5, 2003

Dear Mr. Brophy:

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. Iisting 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. Stephen Brophy

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,

Mark M Mallerson

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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K023852

Page 1 of 1

### 510(k) NUMBER (IF KNOWN) :

DEVICE NAME : "Stairfriend" Curved Stairway Chairlift

### INDICATIONS FOR USE:

The product will be used by patients to assist in navigating a specific set of stairs. This is a selfcontained 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 cannot handle the exertion of walking up and down stairs. Doctors or physical therapists may recommend the unit for those who are recuperating, but a large number of users acquire a stairway elevator just because it eases the burden of climbing 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

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Over-The-C
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Over-The-Counter-Use Optional Format 1)

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and Neurological Devices