The LEVO MAX power wheelchair is intended to provide indoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.
The LEVO MAX power wheelchair is intended to provide indoor and outdoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.

Device Description

The LEVO MAX powered wheelchair with optional seating and function is center wheel motor driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "R-net" or "VR2". The joystick user interface is integrated in the controller. The wheelchair is powered by two 12V/55Ah, 12V/73Ah or two 12V/75Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah); with fully charged batteries.
Components:The LEVO MAX power wheelchair consists of three basic sub-sections. These are: the base with drive units, the PG Drives Technology's R-NET or VR-2 Control System, and the body supporting system.
The base of the LEVO MAX includes: the frame, two direct-drive units with integrated parking brakes, two 12V/55Ah, two 12V/73Ah, or two 12V/75Ah batteries, two straight front and two center driving wheels as well as two twin rear caster wheels.
PG Drives Technology's VR2-Control System includes the power module, the integrated lighting module and the controller with integrated joystick. PG Drives Technology's R-NET Control System includes the power module, the intelligent seating/lighting module and the controller with integrated joystick.
The body supporting system includes the seat support, armrests and leg rests.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LEVO MAX power wheelchair:

The document is a 510(k) summary, which concerns medical device clearance in the US based on substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data. Therefore, the "study" described here is primarily a series of engineering and performance tests based on recognized standards.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the listed standards being "met," meaning the device passed the performance requirements specified in each standard. The document doesn't provide specific quantitative acceptance thresholds for each test, but rather states that the "Levo MAX functioned as intended" in all instances of the performed tests.

Acceptance Criteria (Standards Met)	Reported Device Performance
RESNA WC-1:2009 Section 1: Determination of static stability	"Levo MAX functioned as intended"
RESNA WC-2:2009 Section 2: Determination of dynamic stability of electrically powered wheelchairs	"Levo MAX functioned as intended"
RESNA WC-2:2009 Section 3: Determination of effectiveness of brakes	"Levo MAX functioned as intended"
RESNA WC-2:2009 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical dis.	"Levo MAX functioned as intended" (Theoretical driving range reported as up to 35 km)
RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space	"Levo MAX functioned as intended" (Dimensions: 1300/620/1120 mm, Weight: 170 kg)
RESNA WC-2:2009 Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs	"Levo MAX functioned as intended" (Maximum Speed: Up to 12 km/h)
RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions	"Levo MAX functioned as intended"
RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strength	"Levo MAX functioned as intended"
RESNA WC-2:2009 Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs	"Levo MAX functioned as intended" (Obstacle climbing: 130mm)
RESNA WC-1:2009 Section 11: Test dummies	"Levo MAX functioned as intended"
RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces	"Levo MAX functioned as intended"
RESNA WC-2:2009 Section 14: Power and control systems for electrically powered wheelchairs Requirements and test methods.	"Levo MAX functioned as intended"
RESNA WC-1:2009 Section 15: Requirements for information disclosure, documentation and labeling	"Levo MAX functioned as intended"
RESNA WC-1:2009 Section 16: Resistance to ignition of upholstered parts -Requirements and test methods	"Levo MAX functioned as intended"
RESNA WC-1:2009 Section 22: Set-up procedures	"Levo MAX functioned as intended"
RESNA WC-1:2009 Section 26: Vocabulary	"Levo MAX functioned as intended"
ISO 7176-1:1999: Wheelchairs Part 1: Determination of static stability	"Levo MAX functioned as intended"
ISO 7176-2:2001: Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs	"Levo MAX functioned as intended"
ISO 7176-3:2012: Wheelchairs Part 3: Determination of efficiency of brakes	"Levo MAX functioned as intended"
ISO 7176-4:2008: Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range	"Levo MAX functioned as intended" (Theoretical driving range reported as up to 35 km)
ISO 7176-5:2008: Wheelchairs Part 5: Determination of overall dimensions, mass and turning space	"Levo MAX functioned as intended" (Dimensions: 1300/620/1120 mm, Weight: 170 kg)
ISO 7176-6:2001: Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs	"Levo MAX functioned as intended" (Maximum Speed: Up to 12 km/h)
ISO 7176-7:1998: Wheelchairs Part 7: Measurement of seating and wheel dimensions	"Levo MAX functioned as intended"
ISO 7176-8:1998: Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths	"Levo MAX functioned as intended"
ISO 7176-10:2008: Wheelchairs Part 10: Determination of obstacle climbing ability of electric wheelchairs	"Levo MAX functioned as intended" (Obstacle climbing: 130mm)
ISO 7176-11:2012: Wheelchairs Part 11: Test dummies	"Levo MAX functioned as intended"
ISO 7176-13:1989: Wheelchairs Part 13: Determination of coefficient of friction of test surfaces	"Levo MAX functioned as intended"
ISO 7176-14:2008: Wheelchairs Part 14: Power and control systems for electric wheelchairs - Requirements and test methods	"Levo MAX functioned as intended"
ISO 7176-15:1996: Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling	"Levo MAX functioned as intended"
ISO 7176-16:2012: Wheelchairs Part 16: Resistance to ignition of upholstered parts 1-2	"Levo MAX functioned as intended"
ISO 7176-19:2008: Wheelchairs Part 19 Wheeled Mobility Devices for use as seats in motor vehicles	"Levo MAX functioned as intended"
ISO 7176-22:2000: Wheelchairs Part22: Set-up procedures	"Levo MAX functioned as intended"
EN 12184:2009: Electrically powered wheelchairs, scooters an their chargers	"Levo MAX functioned as intended"
EN 12182:2012: Technical aids for disabled persons. General requirements and test methods	"Levo MAX functioned as intended"
Upcoming Tests (before marketing):RESNA WC-2:2009 Section 9: Climatic tests; RESNA WC-2:2009 Section 21: Electromagnetic compatibility; ISO 7176-9:2009: Climatic tests; ISO 7176-21:2009: Electromagnetic compatibility	"Testing will be conducted and meet the acceptance criteria of the following standards before the device is marketed"

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in the conventional sense for clinical studies. It refers to a single device (the LEVO MAX) undergoing various engineering performance tests.
Data Provenance: The tests were performed to international and national standards (ISO, RESNA, EN), which implies the testing environment would adhere to the specified protocols of these standards. The device manufacturer, LEVO AG, is based in Wohlen, Switzerland. The nature of these tests (e.g., static stability, dynamic stability, brake efficiency) indicates an engineering/benchtop testing environment, not human subject data. The testing is prospective in the sense that the device was actively tested against these standards for the purpose of seeking clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the "ground truth" for these engineering performance tests is defined by the objective physical and mechanical properties and performance of the device against the criteria outlined in the referenced standards. There is no subjective interpretation by human experts being adjudicated to establish ground truth in the way it would be for, e.g., image interpretation in an AI study. The tests are machine-measured or involve objective physical events.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed are objective engineering measurements and evaluations against predefined standard parameters. They do not involve subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a powered wheelchair, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). This document does not describe any MRMC study or AI component.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This is not applicable. There is no "algorithm" or AI component described in the context of this device that would undergo standalone performance testing. The "performance data" refers to the physical performance of the mechanical and electrical system of the wheelchair.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these tests is the quantitative and qualitative performance requirements specified within each referenced engineering standard (RESNA, ISO, EN). For example, a stability test would define the angle at which a wheelchair must remain stable, and the "ground truth" is whether the tested wheelchair meets or exceeds that angle. For speed, the ground truth is the measured speed compared to a specified maximum.
- Examples:
  - Static Stability: The ground truth is the specified tilt angle(s) the wheelchair must withstand without tipping, as defined by the RESNA/ISO standard.
  - Brake Effectiveness: The ground truth is the required stopping distance or holding capability on an incline, as specified by the standard.
  - Dimensions/Weight: The ground truth is the actual measured dimensions and weight of the device.

8. The Sample Size for the Training Set

This is not applicable. There is no AI or machine learning component described that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for an AI model.

Summary of the Study:

The "study" presented here is a series of engineering performance tests conducted on the LEVO MAX power wheelchair. These tests evaluated the device's physical and mechanical characteristics and performance against internationally recognized standards (RESNA, ISO, and EN) for wheelchairs. The purpose was to demonstrate that the LEVO MAX is safe and effective and substantially equivalent to its predicate device, the Permobil M400, by showing it meets or exceeds the performance requirements outlined in these standards. The document explicitly states that "In all instances of the above mentioned test criteria, the Levo MAX functioned as intended," meaning it passed all conducted tests. Additional tests for climatic conditions and electromagnetic compatibility are planned before the device is marketed.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, with flowing lines resembling hair or ribbons extending from the profiles. The profiles are arranged in a staggered formation, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 21, 2015

LEVO AG Andrew Dvorak Engineer Anglikerstrasse 20 CH-5610 Wohlen, Switzerland

Re: K140706

Trade/Device Name: LEVO MAX (MAX 100, MAX 200, MAX 300) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 10, 2014 Received: December 17, 2014

Dear Mr. Dvorak:

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. Isting 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Felipe Aquel -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K140706

Device Name LEVO MAX (MAX 100, MAX 200, MAX 300)

Indications for Use (Describe)

The LEVO MAX power wheelchair is intended to provide indoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for LEVO. The logo is in red and features the word "LEVO" in a bold, sans-serif font. To the right of the word "LEVO" is ".ot" with a small Swiss flag in the upper right corner. Below the logo is the tagline "THE EXPERTS IN STANDING" in a smaller, gray font.

510(k) Summary

Submitter:	LEVO AGP.O. Box 1272Anglikerstrasse 20CH-5610 Wohlen, Switzerland
Phone:Fax:	+41 56-6184411+41 56-6184410
Contact Person:	Mr. Andrew Dvorak, EngineerMr. Rob Sink; PE, General Manager
E-Mail-Address:	andyd@danetechnologies.com robs@danetechnologies.com
Date Prepared	June 27th, 2014
Device Name:	LEVO MAX
Common name:	Power Wheelchair
Classification Name:	Wheelchair, Powered; (21 CFR 890.3860, Product Code ITI)
Predicate Devices:	Permobil M400(K123290)

The LEVO MAX power wheelchair is intended to provide indoor and Intended Use: outdoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.

Technological Characteristics and Substantial Equivalence

Device Description: The LEVO MAX powered wheelchair with optional seating and function is center wheel motor driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "R-net" or "VR2". The joystick user interface is integrated in the controller. The wheelchair is powered by two 12V/55Ah, 12V/73Ah or two 12V/75Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah); with fully charged batteries.

Components:The LEVO MAX power wheelchair consists of three basic sub-sections. These are: the base with drive units, the PG Drives Technology's R-NET or VR-2 Control System, and the body supporting system.

The base of the LEVO MAX includes: the frame, two direct-drive units with integrated parking brakes, two 12V/55Ah, two 12V/73Ah, or two 12V/75Ah batteries, two straight front and two center driving wheels as well as two twin rear caster wheels.

PG Drives Technology's VR2-Control System includes the power module, the integrated lighting module and the controller with integrated joystick. PG Drives Technology's R-NET

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Control System includes the power module, the intelligent seating/lighting module and the controller with integrated joystick.

The body supporting system includes the seat support, armrests and leg rests.

Performance Data:

Testing was performed in accordance with the following standards:

· RESNA WC-1:2009 Section 1: Determination of static stability.
· RESNA WC-2:2009 Section 2: Determination of dynamic stability of electrically powered wheelchairs.
RESNA WC-2:2009 Section 3: Determination of effectiveness of brakes.
Section 4: Energy consumption of electrically powered wheelchairs · RESNA WC-2:2009 and scooters for determination of theoretical dis.
RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space
RESNA WC-2:2009 Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs
· RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions
RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strength
RESNA WC-2:2009 Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
RESNA WC-1:2009 Section 11: Test dummies
RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces
RESNA WC-2:2009 Section 14: Power and control systems for electrically powered wheelchairs Requirements and test methods.
RESNA WC-1:2009 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
RESNA WC-1:2009 Section 16: Resistance to ignition of upholstered parts -Requirements and test methods
RESNA WC-1:2009 Section 22: Set-up procedures
RESNA WC-1:2009 Section 26: Vocabulary
· ISO 7176-1:1999 Wheelchairs Part 1: Determination of static stability
ISO 7176-2:2001 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs
· ISO 7176-3:2012 Wheelchairs Part 3: Determination of efficiency of brakes
ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs Part 5: Determination of overall dimensions, mass and turning space
ISO 7176-6:2001 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:1998 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle climbing ability of electric wheelchairs
· ISO 7176-11:2012 Wheelchairs Part 11: Test dummies

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Image /page/5/Picture/1 description: The image shows the logo for LEVO.d, a company that specializes in standing. The logo is in red and features the company name in a stylized font. The words "THE EXPERTS IN STANDING" are written in smaller letters below the company name. There is a Swiss flag to the right of the company name.

LEVO POWERED WHEELCHAIR: MAX

ISO 7176-13:1989 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces
· ISO 7176-14:2008 Wheelchairs Part 14: Power and control systems for electric wheelchairs - Requirements and test methods
· ISO 7176-15:1996 Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16:2012 Wheelchairs Part 16: Resistance to iqnition of upholstered parts 1-2
ISO 7176-19:2008 Wheelchairs Part 19 Wheeled Mobility Devices for use as seats in motor vehicles
· ISO 7176-22:2000 Wheelchairs Part22: Set-up procedures
EN 12184:2009 Electrically powered wheelchairs, scooters an their chargers
EN 12182:2012 Technical aids for disabled persons. General requirements and test methods

In all instances of the above mentioned test criteria, the Levo MAX functioned as intended.

Performance Data continued:

Testing will be conducted and meet the acceptance criteria of the following standards before the device is marketed:

RESNA WC-2:2009 Section 9: Climatic tests for electrically powered wheelchairs
Section 21: Requirements and test methods for electromagnetic • RESNA WC-2:2009 compatibility of electrically powered wheelchairs
ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
ISO 7176-21:2009 Wheelchairs Part21: Requirements and test methods for electromagnetic compatibility

Substantial Equivalence:

The LEVO MAX is substantially equivalent to the cleared predicate devices, the Permobil M400, as outlined in the following table:

Characteristic	LEVO MAX	Permobil M400
Intended use	The LEVO MAX powerwheelchair is intendedto provide indoor andoutdoor mobility topersons restricted to asitting position that arecapable of operating apowered wheelchair.	To provide indoor andoutdoor mobility topersons restricted to asitting position that arecapable of operating apowered wheelchair
Type of base	Mid wheel driven	Mid wheel driven
Caster wheelDimension	7" twin	200x50 mm
Drive wheelDimension	3.00-8"	3.00-8"
Adjustable Anti-Tip wheels	The front and rearwheels function asanti-tip devices	The front and rearwheels function as anti-tip devices
Over all Dimensions l/w/h(mm)	1300/620/1120	1256/620/1260
Weight incl.batteries	170 kg	155 kg

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Image /page/6/Picture/1 description: The image shows the logo for LEVO. The logo is in red and features the word "LEVO" in a bold, sans-serif font. To the right of the word "LEVO" is ".ot" with a registered trademark symbol underneath the "o". Above the ".ot" is a white cross on a red square. Below the logo is the text "THE EXPERTS IN STANDING" in a smaller, gray font.

Weight bearingcapacity	160 kg	136kg
Maximum Speed	Up to 12 km/h	Up to 12 km/h
Brake System	Electronic braking viadrive motors andmagnetic parkingbrakes	Electronic braking viadrive motors andmagnetic parking brakes
Ground clearance	72mm	77mm
Obstacle climbing	130mm	70mm
Turning Radius	600mm	800mm
Driving Range	Up to 35 km	Up to 25 km

The LEVO MAX is substantially equivalent to the Permobil M400(#K123290). The LEVO MAX has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the LEVO MAX and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the LEVO MAX is as safe and effective as its predicate devices. Thus, the LEVO MAX, Permobil M400 are substantially equivalent.

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).