(100 days)
Not Found
No
The description details a standard powered wheelchair with linear actuators and a joystick control, without mentioning any AI/ML components or capabilities. The performance studies listed are standard electrical and mechanical safety tests.
No
A therapeutic device is one that treats or heals an ailment or condition. This device is a powered wheelchair designed for mobility assistance, which manages a condition but does not treat or heal it.
No
Explanation: The device is described as a "powered standup wheelchair" intended for providing mobility to users with ambulatory impairments. Its description focuses on mechanical and electrical components related to movement and positioning, not on collecting or analyzing data for diagnosis.
No
The device description clearly outlines numerous hardware components including motors, batteries, actuators, chassis, wheels, and brakes. The performance studies also focus on testing the physical characteristics and safety of a powered wheelchair, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "electrical powered seated and standing mobility to users with ambulatory impairments." This describes a device used on a patient for physical support and mobility, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a powered wheelchair with features for mobility and positioning. This aligns with a physical assistance device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies listed are related to the safety, stability, and functionality of a mobility device (e.g., electrical safety, stability, strength, climatic tests), not the analytical or clinical performance of a diagnostic test.
- Predicate Device: The predicate device is another powered wheelchair (LCM by LEVO), further confirming the device's classification as a mobility aid.
In summary, the LSC Lifestand Compact is a medical device, but it falls under the category of a mobility aid or powered wheelchair, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IPL
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.
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
Not Found
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
Non-Clinical Tests Performed: 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; 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.
Clinical Tests Performed: Clinical tests were not performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
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 |
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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 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 |
ട്. 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 |
| 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
3
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.
4
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.
5
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
6
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)
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)
Muriam C. Provost
(Division Sign. Division of General, Restorative. and Neurological Devices
510(k) Number: K041535