(168 days)
Not Found
No
The summary describes a powered standup wheelchair with standard mechanical and electrical components for mobility and positioning. There is no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is a powered standup wheelchair designed for mobility and does not provide therapy or treatment for medical conditions.
No
The provided text describes a powered wheelchair (LSC) designed to provide mobility and assist with standing for users with ambulatory impairments. Its function is to assist with mobility, not to diagnose a medical condition.
No
The device description clearly states it is a "powered standup wheelchair" with physical components like wheels, castors, and an electric linear actuator system, indicating it is a hardware device with electrical components, 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 clearly states that the device provides "electrically powered seated and standing mobility to users with ambulatory impairments." This describes a device used for physical support and mobility, not for examining specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "powered standup wheelchair" with features related to propulsion, steering, and positioning. This aligns with a mobility aid, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
Therefore, based on the provided text, the LSC is a mobility device and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LSC offers electrically operated seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifibia, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
The LSC is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the caain and allow indirect steering through the turning back wheels. An electric lineanan anot system puts the seat into a seating or standing position.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed for Determination of Substantial Equivalence: To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies.
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
§ 890.3900 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
K061726
Page 1 of 3
EXHIBIT #1
Image /page/0/Picture/1 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there is an abstract graphic that appears to be composed of vertical lines of varying heights. The lines are arranged in a way that suggests a stylized representation of a cityscape or a series of standing figures. The overall design is simple and modern.
LifeStand "Vivre-Debout" Rond-point de Rosarge 40, rue Palverne - 01700 LES ECHETS-FRANCE Tel : +33(0)4 37 26 27 28 Fax :+33(0)4 37 26 27 29 VAT :FR 23 312 906 613 00079
BEC - 4 2006
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:________________________________________________________________________________________________________________________________________________
-
- Submitter's Identification:
Lifestand Rond-point de Rosarge 40, rue Palverne F 01700 LES ECHETS-FRANCE
- Submitter's Identification:
Date Summary Prepared: June 12, 2006
-
- Name of the Device: LSC
-
- Common or Usual Name:
powered standup wheelchair
4. Device Description:
The LSC is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the caain and allow indirect steering through the turning back wheels. An electric lineanan anot system puts the seat into a seating or standing position.
| Maximum end-user weight | : | 120 kg |
|---|---|---|
| Wheelchair width | : | 67 cm |
| Wheelchair length | : | 87-109 cm |
| Frame | : | Rigid, in magnesium, epoxy paint |
| Seat | : | Depth adjustable, with sore proof cushion |
| Backrest | : | Inclinable. Folds down for transport |
| Upholstery | : | Polyester fireproof material (M4), washable |
| Foot-rests | : | Height adjustable |
| Front wheels | : | Ø 200mm x 50mm, solid |
| Rear wheels | : | Ø 350mm x 70mm, solid |
| Brakes | : | automatic electro-magnetic brake and |
| manual standard parking brake | ||
| Propulsion | : | electric powered |
| Elevation | : | electric powered |
| Rear stabilization | : | Anti-tip wheels (optional). |
| Idle weight | : | 94.7kg |
5. Intended Use:
1
Image /page/1/Picture/1 description: The image shows a logo with the text "LIFESTA" at the bottom. Above the text, there are three vertical lines of varying heights. The lines appear to be connected at the top, forming a stylized graphic element. The image is in black and white.
The LSC offers electrically operated seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifibia, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
6. Comparison to Predicate Devices:
The LSC is substantially equivalent to its forerunner model LSC Compact by Lifestand, K041535 and the standup wheelchair LCM by LEVO, K963817
- Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies:
| EN 12182: 1999 | Technical aids for disabled persons. General requirements
and test methods |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| EN 12184: 1999 | Electrically powered wheelchairs, scooters and their chargers
-requirements and test methods |
| ISO 7176-1: 1999 | Wheelchairs. Determination of static stability |
| ISO 7176-2: 2001 | Wheelchairs. Determination of dynamic stability of electric
wheelchairs |
| ISO 7176-3: 1988 | Wheelchairs. Determination of effectiveness of brakes |
| ISO 7176-4: 1997 | Wheelchairs. Energy consumption of electric wheelchairs and
scooters for determination of theoretical distance |
| ISO 7176-5: 1986 | Wheelchair tests. Methods for determination of overall
dimensions, mass and turning space |
| ISO 7176-6: 2001 | Wheelchairs. Determination of maximum speed, acceleration
and deceleration of electric wheelchairs |
| ISO 7176-7: 1998 | Wheelchairs. Measurement of seating and wheel dimension |
| ISO 7176-8: 1998 | Wheelchairs. Requirements and test methods for static,
impact and fatigue strength |
| ISO 7176-9: 2001 | Wheelchairs. Climatic test for electric wheelchairs |
| ISO 7176-10: 1988 | Wheelchairs. Determination of obstacle-climbing ability of
electric wheelchairs |
| ISO 7176-14: 1997 | Power and Control systems for electric wheelchairs –
Requirements and test methods |
| ISO 7176-15: 1996 | Wheelchairs. Requirements for information disclosure,
documentation and labeling |
| ISO 7176-16: 1997 | Wheelchairs - Part 16: Resistance to ignition of upholstered
parts - Requirements and test methods |
| ISO 7176-20: 2001 | Wheelchairs. Determination of the performance of stand-up
type wheelchairs |
| ISO 7176-21: 2003 | Wheelchairs. Requirements and test methods for
electromagnetic compatibility of electrically powered
wheelchairs and motorized scooters |
| EN ISO 10993-1: 2003 | Biological evaluation of medical devices. Evaluation and
testing |
2
Image /page/2/Picture/0 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there is an abstract graphic that appears to be three vertical lines of varying heights. The lines are not solid but seem to be made up of smaller elements, giving them a textured appearance.
K061726
Page 3 of 3
Biological evaluation of medical devices. Tests for in vitro EN ISO 10993-5: 1999 cytotoxicity
- Discussion of Clinical Tests Performed: 8. Clinical tests were not performed
-
- Conclusions:
Lifestand believes that the LSC is substantially equivalent to the predicate and is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2006
LifeStand "Vivre-Debout" % Ms. Stefanie D. Bankston Rond-point de Rosarge 40, rue Palverne F 01700 Les Echets- France
Re: K061726
Trade/Device Name: LSC Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: November 20, 2006 Received: November 28, 2006
Dear Ms. Bankston:
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.
4
Page 2 – Ms. Stefanie D. Bankston
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 (240) 276-0120 . 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Cahmz
Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit #3
Page ﻠﺴﻴ of 1
K061726 510(k) Number (if known):
Device Name: LSC
Indications For Use:
The LSC offers electrically 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number. K061726