The LSC Lifestand Compact offers electrical powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

Device Description

The LSC Lifestand Compact is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels using independent motors. Front castors support the front of the chair and allow indirect steering through the turning hack wheels. The system is controlled with a standard e-fix wheelchair controller, with direct user operation through standard wheelchair joystick. Two high quality maintenance-free watertight rechargeable electrolyte gel batteries, connected in series, supply the energy for the system. A Lincar actuator drives the seat into seating or standing position. Another linear actuator drives the backrest into an individual seating-inclination. Both linear actuators are also direct user operated through the standard wheelchair ion: Dots.

Chassis: Rigid, made from treated steel with epoxy resin paint
Tibia support: adjustable in height and inclination
Seat: Depth adjustable with cushion
Backrest: electrically adjustable
Armrest: Retractable, can be converted to adjustable chest support
Footrest: Height can be adjusted
Upholstery: Fire-resistant (M4), washable fabric
Front wheels: diameter 7" x 1 3/4"
Rear wheels: diameter 12 1/2" x 2 1/4"
Brakes: manual by pushing and electromagnetic in the back wheels
User weight: max. 120kg
Idle weight: 76kg
Batteries: 2x12V, 17Ah, watertight rechargeable electrolyte gel batteries
Driving-motor: e-fix by Ulrich Alber GmbH + Co. KG – Germany, 24V DC
Linear actuator seat: Linac LA 31.1
Linear actuator back: Linac 314210

AI/ML Overview

The provided document describes a 510(k) premarket notification for the LSC Lifestand Compact, an electrically powered standup wheelchair. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Met)	Reported Device Performance
EN 12184: 1999 Electrically powered wheelchairs, scooters and their chargers requirements and test methods	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 12182: 1999 Technical aids for disabled persons - general requirements and test methods	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-1: 1999-10-01 Determination of static stability	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-2: 2001-06-15 Determination of dynamic stability of electric wheelchairs	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-3: 1988-11-15 Determination of efficiency of brakes	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-4: 1997-12-15 Energy consumption of electric wheelchairs and scooters for determination of theoretical distance	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-5: 1986-03-01 Determination of overall dimensions, mass and turning space	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-6: 2001-10-01 Determination of maximum speed, acceleration and deceleration of electric wheelchairs	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-7: 1998-05-15 Measurement of seating and wheel dimensions	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-8: 1998-07-15 Static, impact and fatigue strength	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-9: 2001-10-15 Climatic tests for electric wheelchair	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-10: 1988-11-15 Determination of obstacle-climbing ability of electric wheelchairs	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-14: 1997-10-15 Power and control systems for electric wheelchairs – Requirements and test methods	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 7176-15: 1996-11-00 Requirements for information disclosure, documentation and labeling	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO/CD 7176-20: 2001-07-06 Determination of the performance of stand-up type wheelchairs	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ANSI/RESNA WC/Vol. 2-1998 Section 21 Requirements and Test Methods for Electromagnetic Compatibility of Electric Wheelchairs and Scooters	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 55011: 1998 Limits and methods of measurement of radio disturbance characteristics of information technology equipment	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
CISPR 11: 1997 Industrial, scientific and medical (ISM) radio-frequency equipment – Radio disturbance characteristics – Limits and methods of measurement, Amendment No. 1 (1999)	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 61000-4-2: 1995 Electromagnetic Compatibility (EMC), Part 4: Testing and measuring techniques, Section 2: Electrostatic discharge immunity test	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 60601-4-3: 1996 Electromagnetic Compatibility (EMC), Part 4: Testing and measuring techniques, Section 3: Radiated, radio-frequency electromagnetic field immunity test	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 60335: 1995 Specification for safety of household and similar electrical appliances	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 50081-1: 1993 Electromagnetic compatibility. Generic emission standard. Residential, commercial and light industry	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN 50082-2: 1996 Electromagnetic compatibility. Generic immunity standard. Industrial environment	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
EN ISO 10993-5: 1999 Biological evaluation of medical devices. Tests for in vitro cytotoxicity	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
NFX 41002 Resistance to salt spray fog	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
NFP 92503 flammability	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
NFP 92505 flammability	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).
ISO 6941:1984 Textile fabrics. Burning behavior. Measurement of flame spread properties of vertically oriented specimens	"The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval).

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical tests performed on the LSC Lifestand Compact. The document states: "The following tests where performed on the LSC standup wheelchair to approve its safety" and then lists a comprehensive set of national and international standards related to electrically powered wheelchairs, general technical aids for disabled persons, and various aspects of safety, performance, and electromagnetic compatibility.

The implicit finding from this submission is that the LSC Lifestand Compact successfully met the requirements of all listed standards, thereby demonstrating its safety and effectiveness for its intended use, and establishing substantial equivalence to the predicate device.

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

Sample Size for Test Set: The document does not explicitly state the sample size of the LSC Lifestand Compact devices used for these non-clinical tests. Typically, for such product safety and performance testing against standards, a representative sample (often one or a few units) of the manufactured device is subjected to the tests.
Data Provenance: The tests are non-clinical, meaning they were performed on the device itself, not on human subjects. The company is based in France ("Lifestand Rond Point de Rosarge 40, rue Palverne F-01700 Les Echets - France"), suggesting the testing may have occurred in Europe or by laboratories accredited to perform these standards. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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

These are non-clinical engineering and performance tests, not clinical studies involving expert interpretation of data like medical imaging. Therefore, the concept of "experts establishing ground truth" in the clinical sense does not apply here. The "ground truth" for these tests is defined by the objective pass/fail criteria set forth in each listed international and national standard. The evaluations would have been performed by qualified testing personnel and engineers, whose qualifications would be in the field of mechanical, electrical, and materials engineering, and testing methodologies specific to medical devices and wheelchairs.

4. Adjudication Method for the Test Set

Not applicable. Since these are objective performance tests against predefined standards, there is no "adjudication method" in the sense of resolving discrepancies between human readers or experts. The outcome of each test is determined by whether the device's performance meets the specified thresholds or criteria in the respective standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is a type of clinical study typically used to compare the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm when interpreting medical data. This document describes the non-clinical testing of a physical medical device (an electric wheelchair) against established engineering and safety standards. No clinical studies, and therefore no MRMC studies, were performed or are relevant to this submission.

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

Not applicable. This device is a physical, electrically powered wheelchair; it is not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For non-clinical performance and safety testing of a physical device, the "ground truth" is established by the objective, predefined pass/fail criteria and specifications outlined in the referenced national and international standards (e.g., EN 12184, ISO 7176 series, ANSI/RESNA, EN 61000, etc.). For example, the "ground truth" for static stability (ISO 7176-1) would be the device remaining stable under specific load and incline conditions, as defined by that standard.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied in this document. The device is a physical product, not an AI algorithm that requires training data.

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

Not applicable, as there is no training set for this type of device and submission.

Summary

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K04/535

SEP 16 2004

EXHIBIT #1

1/4

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Lifestand Rond Point de Rosarge 40, rue Palverne F-01700 Les Echets - France Tel: +33(0)4 37 26 27 28 Fax: +33(0)4 37 26 27 29

Date Summary Prepared: June 7, 2004

2. Name of the Device:

LSC Lifestand Compact

3. Common or Usual Name:

Electrical powered standup wheelchair

4. Device Description:

Chassis:	Rigid, made from treated steel with epoxy resin paint
Tibia support:	adjustable in height and inclination
Seat:	Depth adjustable with cushion
Backrest:	electrically adjustable
Armrest:	Retractable, can be converted to adjustable chest support
Footrest:	Height can be adjusted

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Ko41535

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Upholstery:	Fire-resistant (M4), washable fabric
Front wheels:	$\varnothing$ 7" x $1 \frac{3}{4}$ "
Rear wheels:	$\varnothing$ 12 $\frac{1}{2}$ " x 2 $\frac{1}{4}$ "
Brakes:	manual by pushing andelectromagnetic in the back wheels
User weight:	max. 120kg
Idle weight:	76kg
Batteries:	2x12V, 17Ah, watertight rechargeable electrolyte gel batteries
Driving-motor:	e-fix by Ulrich Alber GmbH + Co. KG – Germany, 24V DC
Linear actuator seat:	Linac LA 31.1
Linear actuator back:	Linac 314210

ട്. Intended Use:

6. Comparison to Predicate Devices:

The LSC Lifestand is substantially equivalent in design and intended use to the standup wheelchair LCM by LEVO, K963817

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

The following tests where performed on the LSC standup wheelchair to approve its safety;

EN 12184: 1999	Electrically powered wheelchairs, scooters and their chargersrequirements and test methods
EN 12182: 1999	Technical aids for disabled persons- general requirements andtest methods
ISO 7176-1: 1999-10-01	Determination of static stability
ISO 7176-2: 2001-06-15	Determination of dynamic stability of electric wheelchairs
ISO 7176-3: 1988-11-15	Determination of efficiency of brakes
ISO 7176-4: 1997-12-15	Energy consumption of electric wheelchairs and scooters fordetermination of theoretical distance
ISO 7176-5: 1986-03-01	Determination of overall dimensions, mass and turning space
ISO 7176-6: 2001-10-01	Determination of maximum speed, acceleration anddeceleration of electric wheelchairs
ISO 7176-7: 1998-05-15	Measurement of seating and wheel dimensions
ISO 7176-8: 1998-07-15	Static, impact and fatigue strength
ISO 7176-9: 2001-10-15	Climatic tests for electric wheelchair
ISO 7176-10: 1988-11-15	Determination of obstacle-climbing ability of electric wheelchairs
ISO 7176-14: 1997-10-15	Power and control systems for electric wheelchairs – Requirements and test methods
ISO 7176-15: 1996-11-00	Requirements for information disclosure, documentation and labeling
ISO/CD 7176-20: 2001-07-06	Determination of the performance of stand-up type wheelchairs
ANSI/RESNA WC/Vol. 2-1998 Section 21	Requirements and Test Methods for Electromagnetic Compatibility of Electric Wheelchairs and Scooters
EN 55011: 1998	Limits and methods of measurement of radio disturbance characteristics of information technology equipment
CISPR 11: 1997	Industrial, scientific and medical (ISM) radio-frequency equipment – Radio disturbance characteristics – Limits and methods of measurement, Amendment No. 1 (1999)
EN 61000-4-2: 1995	Electromagnetic Compatibility (EMC), Part 4: Testing and measuring techniques, Section 2: Electrostatic discharge immunity test
EN 60601-4-3: 1996	Electromagnetic Compatibility (EMC), Part 4: Testing and measuring techniques, Section 3: Radiated, radio-frequency electromagnetic field immunity test
EN 60335 : 1995	Specification for safety of household and similar electrical appliances
EN 50081-1: 1993	Electromagnetic compatibility. Generic emission standard. Residential, commercial and light industry
EN 50082-2: 1996	Electromagnetic compatibility. Generic immunity standard. Industrial environment
EN ISO 10993-5: 1999	Biological evaluation of medical devices. Tests for in vitro cytotoxicity
NFX 41002	Resistance to salt spray fog
NFP 92503	flammability
NFP 92505	flammability
ISO 6941:1984	Textile fabrics. Burning behavior. Measurement of flame spread properties of vertically oriented specimens

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K041535 3/4

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K041535 4/4

Discussion of Clinical Tests Performed: 8.

Clinical tests were not performed

9. Conclusions:

Lifestand believes that the LSC Lifestand Compact is substantially equivalent to the predicate and is safe and effective for it's intended use.

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Public Health Service

SEP 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lifestand C/o Carolann Kotula MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K041535

Trade/Device Name: LSC LifeStand Compact Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: September 2, 2004 Received: September 3, 2004

Dear Ms. Kotula:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreases of the enactment date of the Medical Device Amendments, or to connaice proc to rite) 2015-11-31
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de necs that have been routed of require approval of a premarket approval application (PMA). allu Cosmetic Act (110) market the device, subject to the general controls provisions of the Act. The Tournaly, therefore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device to such additional controls. Existing major regulations affecting your device can may oc subject to back address and egulations, 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 1 that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a coulations administered by other Federal agencies. You must or any I coural butther and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N Fart 077, Mosters (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 – Ms. Carolann Kotula

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mainty of substantial equivalence of your device to a legally premits in the aron. The PDF maing of bactualian 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 If you desire specific acrice 101 your as 1) 594-4659. Also, please note the regulation entitled, Comacs the Office of Complanes an (21CFR Part 807.97). You may obtain Misolaining Uy reference to presidentibilities under the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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Exhibit #5

1 of Page _

510(k) Number (if known): K041535

Device Name: LSC LifeStand Compact

Indications For Use:

The LSC LifeStand Compact offers electrical powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFT 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign. Division of General, Restorative. and Neurological Devices

510(k) Number: K041535

Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).