LIFTKAR PT

K111858 · Sano Transportgeraete GmbH · ILK · Nov 4, 2011 · Physical Medicine

Device Facts

• Record ID: K111858
• Device Name: LIFTKAR PT
• Applicant: Sano Transportgeraete GmbH
• Product Code: ILK · Physical Medicine
• Decision Date: Nov 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The product is a method of transporting a disabled person up and down stairs while seated on the stairclimber and not in a wheelchair. This is done with a battery powered lifting mechanism. The LIFTKAR PT-S requires a certified attendant and can be use on any stairs indoor or outside.

Device Story

LIFTKAR PT-S is an attendant-operated, battery-powered stair-climbing device; transports disabled individuals seated in an integrated chair rather than a wheelchair. Device consists of three lightweight, dismantlable parts: climber unit with seat, battery pack, and handle/backrest assembly. Operated by a trained, certified attendant; used in indoor and outdoor environments. Powered by 24V sealed lead gel batteries; lifting mechanism enables movement up and down stairs at speeds of 10-18 steps per minute. Provides mobility assistance for individuals unable to navigate stairs independently. Attendant controls movement via handle; device design facilitates storage and transport. Benefits include increased accessibility and safe vertical transport for mobility-impaired users.

Clinical Evidence

Bench testing only. Device tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH. Conforms to ISO 7176-23:2002 (Requirements and Test Methods for attendant-operated stair climbing devices) and DIN EN ISO 10993-5 (Biocompatibility/Cytotoxicity).

Technological Characteristics

Materials: Sealed lead gel battery. Energy: 24V battery-powered lifting mechanism. Dimensions: 44.49" height, 19.88" width, 29.3" depth. Weight: 67 lbs. Capacity: 352 lbs. Connectivity: None. Sterilization: N/A. Operation: Attendant-controlled, manual steering with motorized climbing. Standards: ISO 7176-23:2002, DIN EN ISO 10993-5.

Indications for Use

Indicated for disabled persons requiring assistance for transport up and down stairs. Requires a trained and certified attendant for operation. Suitable for indoor and 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

• C-Max-U2 (K103122)

Submission Summary (Full Text)

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# KIII858

NOV - 4 2011

#### 510(k)Summary

#### SANO Transportgerate GmbH LIKFTKAR PT™ -S, Powered Patient Transport Device PRODUCT CODE ILK Regulation Name Powered Patient Transport 890.5150 Class II

#### Submitter's Information

SANO Transportgeraete Gmbh Am Holzpoldigut 22 Lichtenberg/Linz Upper Austria 4040 Austria Telephone [phone] Fax 43 (0_7239/510-10-14 Manfred Winkler Managing Director

Dated Prepared: 08/21/11 Revised on 10.5.11

#### Name of Device and Sponsor LIFTKAR PT™-S Product of SANO

Common Name Integrated Seat Stairclimber

### Classification Name

Powered Patient Transport

Predicate Device C-Max-U2 (AAT Alber Antriebstechnik GmbH) K103122

#### *Intended Use

The product is a method of transporting a disabled person up and down stairs while seated on the stairclimber and not in a wheelchair. This is done with a battery powered lifting mechanism. The LIFTKAR PT-S requires a certified attendant and can be use on any stairs indoor or outside.

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K111858

#### Device Description

The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance.

*Attendants are trained and certified before using the device.

The portable stair-climber LIFTKAR PT-S can be dismantled into three parts, the climber unit with integrated seat, the battery pack and the handle which includes backrest and armrest. All parts are lightweight and easy to stow away.

| Product | PT-S |
|---------------------------------|--------------------------------------------------------|
| Technical Data | |
| Weight (total): | 67 lbs |
| Safe Workload (incl. chair | 352 lbs persons wt. |
| Overall height: | 44.49 inches |
| Overall width: (w/o armrests) | 19.88 inches |
| Depth (footrest out) | 29.3 inches |
| *Stair Landing minimum: stairs) | 31.5 x 35.4 inches (Includes landings for all types of |
| Maximum Stair Height | 8.25 inches |
| *Any Stair Type Depth: | 6 inches (includes winding) |
| *Straight stair width: | 23.81 inches (includes Liftkar plus 3.93 inches) |
| *Winding Stair Width: | 23.81 inches from point of stair depth of 6 inches |

Battery

Sealed lead gel

Capacity with fully charged batter 300-500 steps

Battery capacity

2x 12V5 ah

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# KI11858

#### Nominal output voltage of charged

24 V

Main components: Handle, lifting device, battery

*Climbing Speeds

10 steps per minute I

14 steps per minute II

III 18 steps per minute

Continuous Mode may be used, if stairs are straight, and there is no landing. Contiuous mode is 18 steps per minute. It is recommended for professional use only.

### Liftkar PT-S

Image /page/2/Picture/10 description: The image shows a stair climbing wheelchair. The wheelchair has a black seat and backrest, with armrests on either side. It has a handle at the top for pushing, and wheels at the bottom for moving. The wheelchair is designed to help people with mobility issues climb stairs.

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K11/858

#### Substantial Equivalence

The LIFTKAR PT™ S is substantially equivalent in intended use, design and function to the C-Max-U2 K103122 manufactured by AAT.

C-Max

Image /page/3/Picture/4 description: The image shows two different views of what appears to be a stair climbing wheelchair. The top view shows the wheelchair in its upright and functional configuration, with a seat, backrest, armrests, and wheels. The bottom view shows the wheelchair folded or collapsed, presumably for storage or transport, with the seat and backrest folded down and the frame compacted.

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> ్రామ 35

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# KII1858

Listed Below are the similarities or differences:

#### Product Comparison

| Weight (total): | 78.7 lbs | 67 lbs |
|-----------------------------------------------------|------------------------|---------------------|
| Safe Workload (incl. chair) | 352 lbs | 352 lbs persons wt. |
| Overall height: | 44.4 inches | 44.49 inches |
| Overall width: (w/o armrests) | 16.9 inches | 19.88 inches |
| Depth (footrest out) | 30.9 inches | 29.3 inches |
| Stair Landing minimum: | 31.5 x 35.4 inches | 31.5 x 35.4 inches |
| Maximum Stair Height | 8.26 inches | 8.25 inches |
| Battery | Sealed lead acid | Sealed lead gel |
| Capacity with fully charged battery | 300 steps | 300-500 steps |
| *Speeds | 8-23 steps/min | 10-18 steps/min |
| | Continually adjustable | Continuous Mode |
| Battery capacity | 2x 12V 5 ah | 2x 12V5 ah |
| Nominal output voltage of charge | 24V | 24 V |
| Main components:<br>Handle, lifting device, battery | Same | Same |

C-Max-U2

PT-S

#### Performance Data

The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32

LIFTKAR PT -S conforms with the following standards :

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ISO 7176-23:2002 Requirements and Test Methods for attendant - operated stair climbing devices

Biocompatibility DIN EN ISO 10993-5 Biological Evaluation and testing of Cytotoxicity

The performance Data results of the testing confirm that the device meets specifications for performance criteria and the functions it was intended for. And is substantially equivalent to the predicate device.

#### Conclusion

Based on the design, performance specifications, testing, and intended use, the LIFTKAR PT™ -S is substantially equivalent to the legally marketed device, C-Max k103122

Since the device is essentially the same as the powered patient transporter already marketed, (C-Max K103122), no effect on the safety and or effectiveness of the device is expected.

* Denotes corrections made or added relating to 9.28.11 from FDA re: K111858 Liftkar PT-S (Also underlined)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

SANO Transportgeracte GmbH % Mobility Lifter, LLC Ms. Jeanine A. Carroccio 4028 Belleaire Lane Downers Grove, Illinois 60515

NOV - 4 2011

Re: K111858

Trade/Device Name: LIFTKAR PT™-S Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: September 28, 2011 Received: October 12, 2011

Dear Ms. Carroccio:

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

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Page 2 - Ms. Jeanine A. Carroccio

CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: 《11858

Device Name: LIFTKAR PT™-S

Indications For Use:

The LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside.

| Prescription Use | _______________ |
|------------------|-----------------|
|------------------|-----------------|

AND/OR

Over-The-Counter Use___X__

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sion Sign-Off

(Divisio (Division Sign of Surgical, Orthopedical Division.
and Restorative Devices

510(k) Number K111858