LSC LIFESTAND COMPACT

K041535 · Lifestand · IPL · Sep 16, 2004 · Physical Medicine

Device Facts

• Record ID: K041535
• Device Name: LSC LIFESTAND COMPACT
• Applicant: Lifestand
• Product Code: IPL · Physical Medicine
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

LSC Lifestand Compact is a powered standup wheelchair for users with ambulatory impairments. Device features rigid treated steel chassis, adjustable tibia support, seat, backrest, and armrests. Propulsion and steering achieved via two independent rear-wheel motors controlled by standard joystick-based e-fix controller. Two 12V gel batteries provide power. Two linear actuators enable transition between seated and standing positions and adjust backrest inclination. Operated by user via joystick. Provides mobility and standing capability to assist with daily activities. Bench testing performed per ISO 7176 series and EN standards to verify stability, braking, and electrical safety.

Clinical Evidence

No clinical data. Safety and effectiveness established through non-clinical bench testing, including ISO 7176 series (stability, braking, dimensions, fatigue, obstacle climbing), EN 12184, EN 12182, and electromagnetic compatibility standards (ANSI/RESNA WC/Vol. 2-1998, EN 61000-4-2, EN 60601-4-3). Biocompatibility testing performed per EN ISO 10993-5.

Technological Characteristics

Chassis: treated steel with epoxy resin. Power: 2x12V 17Ah rechargeable electrolyte gel batteries. Motors: 24V DC e-fix motors. Actuation: two linear actuators (Linac LA 31.1, Linac 314210). Brakes: manual and electromagnetic. Dimensions: 7" front wheels, 12.5" rear wheels. Max user weight: 120kg. Connectivity: standard joystick controller. Standards: ISO 7176 series, EN 12184, EN 12182, EN 60335, EN 60601-4-3.

Indications for Use

Indicated for users with ambulatory impairments, including spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, and rheumatism, requiring electrical powered seated and standing mobility.

Regulatory Classification

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.

Predicate Devices

• LCM by LEVO (K963817)

Submission Summary (Full Text)

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K04/535 1/4
SEP 16 2004
EXHIBIT #1

# 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: [phone]
Fax: [phone]
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:

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 back 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 Linear 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 joystick.

| 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 |

Page 1 of 4

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K041535
2/4

Upholstery: Fire-resistant (M4), washable fabric

Front wheels: Ø 7” x 1 3/4”
Rear wheels: Ø 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

## 5. Intended 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.

## 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 chargers - requirements and test methods

EN 12182: 1999 Technical aids for disabled persons- general requirements and test 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 for determination 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 and deceleration of electric wheelchairs

ISO 7176-7: 1998-05-15 Measurement of seating and wheel dimensions

Page 2 of 4

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K041535 3/4

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 4/4

8. **Discussion of Clinical Tests Performed:**

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.

Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 16 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 – Ms. Carolann Kotula

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
for 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
Page 1 of 1

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)
OR
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)

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K041535