LEVANT, HOMEGLIDE

K121560 · Thyssenkrupp Accessibility B.V. · ILK · Nov 1, 2012 · Physical Medicine

Device Facts

• Record ID: K121560
• Device Name: LEVANT, HOMEGLIDE
• Applicant: Thyssenkrupp Accessibility B.V.
• Product Code: ILK · Physical Medicine
• Decision Date: Nov 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ThyssenKrupp Accessibility's Battery Operated Stair Lift Levant is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.

Device Story

Battery-operated stair lift for transport of one mobility-impaired person on straight stairs; indoor and outdoor use. System comprises drive unit, foldable footrest, and anodized aluminum rail fixed to stairs. Operation via 3-position momentary rocker switch; IR call/send functionality. Outdoor option includes waterproof controls, cover, coated electronics/switches, and waterproof charging contacts. Powered swivel and intermediate park position available as options. Device provides mechanical assistance to users with mobility impairments, facilitating navigation of stairs. Healthcare provider/user interaction limited to operation of controls for transit.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, adherence to safety standards (ASME 18.1, EN 81-40), and comparison of mechanical/electrical specifications against predicate devices.

Technological Characteristics

Anodized aluminum rail; ABS synthetic chair (outdoor); direct drive worm gear motor; 8dp gear rack with spur gear; dynamic/electromechanical braking; 24VDC power (2x 7AH batteries); IPx5 electrical enclosure; IR remote control; manual or powered swivel; foldable seat/footrest.

Indications for Use

Indicated for one mobility impaired person requiring mechanical transport up and down straight stairs, for indoor or outdoor use.

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

• Stair Lift BRUNO Independent Living Aids INC (K113308, K033438)

Submission Summary (Full Text)

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NOV. 1

#### 510(k) SUMMARY as required by section 807.92(c)

| Submitted by: | ThyssenKrupp Accessibility BV<br>Van Utrechtweg 99<br>2921 LN Krimpen aan den Ijssel<br>The Netherlands |
|---------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Arnold van der Heiden<br>Mail: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date prepared: | 10/05/2012 |
| Trade Names: | LEVANT/HOMEGLIDE |
| Common Device Name: | Battery Operated Stair Lift for Straight Stairs |
| Regulation Number | 890.5150 |
| Class | II |
| Product Code: | ILK |
| Submission | K121560 |
| Predicate Devices: | Stair Lift BRUNO Independent Living Aids INC<br>K113308, K033438<br>CER 890.5150 |

#### Promotional Product Description

Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs.

It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options.

The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel.

The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.

1 2017

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# Intended Use

ThyssenKrupp Accessibilty's Battery Operated Stair Lift Levant is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.

## Product Comparison Tables

Equivalent Technological Characteristics

| | Bruno SRE-3000/ SRE-2000 | ThyssenKrupp Accessibility Levant |
|----------------|-------------------------------------|------------------------------------|
| Standards | ASME 18.1 | ASME 18.1 |
| Application | Straight stairs | Straight stairs |
| Rated Load | 181 kg | 146 kg |
| Passengers | 1 | 1 |
| Power | 2 pieces 7AH 12 Battery | 2 pieces 7AH 12 Battery |
| Charger | 24VDC/ 2A | Ind:24VDC/ 1700 mA Outd: 6 VAC |
| Drive | Direct drive worm gear motor | Direct drive worm gear motor |
| Final Drive | 8dp gear rack with spur gear | 8dp gear rack with spur gear |
| Braking | Dynamic, worm gear, el/mech brake | Dynamic, worm gear, el/mech brake |
| Call & Send | IR | IR |
| Control | 3-position momentary rocker switch | 3-position momentary rocker switch |
| Supports | Anchored to stair thread | Anchored to stair thread |
| Angle | 22 to 45 degrees, specials up to 52 | 28 to 53 degrees, heavy duty to 45 |
| Speed | 0.08 m/s | 0.12 m/s |
| Track length | 6.1 meters max | 7.5 meters max |
| Construction | Aluminum extrude rail | Anodized aluminum extrude rail |
| Rail Indoors | | |
| Safety devices | Multiple | Multiple |
| Footrest | Folding type | Folding type |
| Seat | Folding type | Folding type |
| Indoor use | Yes | Yes |
| Outdoor use | Yes | Yes |

## Non Equivalent Technological Characteristics

| | Bruno SRE-3000/ SRE-2000 | ThyssenKrupp Accessibility Levant |
|--------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------|
| Temperature<br>range Indoors | SRE-3000 (Bruno ref ILS-01024):<br>not specified | Levant Standard + Comfort option:<br>+5°C to +40°C (41°F to 104°F) |
| Temperature<br>range Outdoors | SRE-2000 (Bruno ref ISO-404.88)<br>-5°C to +50°C (25°F to 125°F) | Levant Outdoor option:<br>-15°C to +60°C (5°F to 140°F) |
| Construction<br>Rail Outdoors | Exterior grade powder coated steel<br>rail | Anodized aluminum extrude rail |
| Construction<br>Chair Outdoors | Stainless steel | ABS Synthetic material |
| Electrical<br>enclosure | IPx3 | IPx5 |

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#### Product Comparison Discussion

Bruno's SRE-3000/ SRE-2000 and ThyssenKrupp Accessibility's Levant show substantial equivalence on most features and characteristics.

- Both products offer a higher rated load then the minimum requested by standards (EN . Doth products offer a mights offers a maximum of 181 kg, where ThyssenKrupp Accessibility offers a maximum of 146 kg.
- Both product offer the possibility to install the rail at the maximum angle of . inclination (EN 75°, ASME 45°). There is a small difference in the angle range, caused by differences in the design.
- Both products a travelling speed that is below the maximum allowed by standards (EN . 0,15 m/s, ASME 0,4 m/s). Bruno specifies a speed of 0,08 m/s where ThyssenKrupp Accessibility offers a speed that is 50% higher.
- Standards do not specify a maximum track length. Bruno offers a maximum track . length of 6,1 meters, where ThyssenKrupp Accessibility offers a maximum track length of 7,5 meters.
- Regarding the temperature range of the outdoor chair versions (Bruno SRE-2000 . stainless steel, Levant Outdoor ABS Synthetic material) there is a difference. Where Bruno offers a minus temperature of 25°F, ThyssenKrupp Accessibility offers a Diano Chero a lemperature of 59F. Where Bruno offers a maximum temperature of 1259F, ThyssenKrupp Accessibility offers a maximum temperature of 140°F.

Small differences as listed above are subject to analysis of specific customer demands by the sales person.

Bruno's SRE-3000/ SRE-2000 and ThyssenKrupp Accessibility's Levant show less substantial equivalence on the features and characteristics listed below.

- ThyssenKrupp Accessibility offers anodized aluminium as rail material, where Bruno t offers exterior grade coated steel. Although substantially different, both materials fulfil the requirements regarding the requested safety factors by the standards. The choice of material is subject to the taste of the end user.
- Bruno offers as protection against spraying water class IPx3, where IPx5 is offered by . ThyssenKrupp Accessibility. IP55 is required by EN 81-40 referenced according IEC Friyssellicrapp Feesssive a required IP level. The substantial difference can be explained by the fact that Levant is a European design, that has to meet EN 81-40. The explained by the fact than be subject of analysis of specific customer demands by the sales person.

Bruno's SRE-3000/ SRE-2000 and ThyssenKrupp Accessibility's Levant show minor Differences in features and characteristics. From the point of view from ThyssenKrupp Technical Advisor, both products can be considered as substantially equal where the I venined frames, or adaption to specific customer demands, creating a bigger chance for mobility impaired persons to find suitable solution.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV

Thyssenkrupp Accessibility B.V. % Mr. Arnold Heiden Technical Advisor Van Utrechtweg 99 Krimpen aan den Ijssel Zuid-Holland, Netherlands 2921 LN

Re: K121560

Trade/Device Name: LEVANT Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: October 24, 2012 Received: October 25, 2012

Dear Mr. Heiden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

1 2012

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## Page 2 - Mr. Arnold Heiden

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

#### Sincerely yours,

Peter D. Rumm -5 2012.11.01 14:50:25 -04'00'

> Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _K121560

Device Name: LEVANT

Indications for Use:

ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to ThyssellRrupp Accessibility S Buttery Opered or son in a fold-down seat, up and down straight stairs, indoors and outdoors.

Prescription Use NO (Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K121560