(127 days)
Not Found
No
The description focuses on a mechanical lifting device with a battery and attendant operation, with no mention of AI or ML capabilities.
No
The device is described as a transportation method for disabled persons, specifically a lifting device to move them up and down stairs. Its intended use is for mobility and transport. While it aids disabled individuals, it does not directly treat or diagnose a medical condition, nor does it deliver therapy.
No
The provided text describes the LIFTKAR PT™-S as a device for transporting disabled persons up and downstairs, not for diagnosing medical conditions. Its function is purely mechanical assistance.
No
The device description clearly states it is a "battery powered lifting device" with an "integrated chair," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for transporting disabled persons up and down stairs. This is a physical mobility aid, not a diagnostic test performed on biological samples.
- Device Description: The description details a battery-powered lifting device with an integrated chair. This aligns with a physical assistance device, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The LIFTKAR PT™-S does not fit this description.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ILK
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.
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.
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: 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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
certified attendant / indoor or outdoor
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. 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.(2)
Classification. Class II. The stairway chair lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(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.
(b)
All other powered patient transport —(1)Identification. 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.(2)
Classification. Class II.
0
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 43(0) 7239/510-10-10 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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1
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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2
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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3
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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୍ଦ
్రామ 35
4
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: | ||
| 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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5
Image /page/5/Picture/0 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by three instances of the number '1'. After the '1's, there is the number '8', then the number '5', and finally the number '2'. The characters are written in a clear, legible font.
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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6
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
7
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 (800) 638-2041 or (301) 796-7100 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
8
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