(143 days)
Not Found
No
The device description focuses on standard powered wheelchair components and control mechanisms (joystick, controller, brakes) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device, a powered wheelchair, provides mobility assistance rather than diagnosing, treating, or preventing disease, which are typical functions of a therapeutic device.
No
This device is a powered wheelchair designed for mobility, not to diagnose a medical condition or disease.
No
The device description clearly outlines numerous hardware components including a frame, motors, batteries, wheels, casters, joystick, and a controller. It is a physical powered wheelchair, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited seating capabilities. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair with mechanical and electrical components for movement. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, anatomical site, and key metrics like sensitivity, specificity, PPV, and NPV. These are common indicators of diagnostic devices, especially those involving analysis of biological data or images.
- Performance Studies: The performance studies focus on compliance with standards related to wheelchair safety and performance (ISO 7176 series), not on the accuracy or reliability of a diagnostic test.
In summary, the F3 powered wheelchair is a medical device designed for mobility assistance, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The intended use of the F3 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The intended use of the F3 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
F3 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick.
The F3 is powered by two 12VDC 60Ah or tow 12VDC 73Ah. Group M34 batteries or Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive wheels with drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest.
When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.
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 Testing:
The F3 complies to the below standards:
- ISO 7176-1: Determination of static stability
- ISO 7176-2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3: Determination of efficiency of brakes
- ISO 7176-4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5: Determination of dimensions, mass and maneuverings space
- ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9: Climatic tests for electric wheelchairs
- ISO 7176-10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11: Test Dummies
- ISO 7176-14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- ISO 7176-15: Requirements for information disclosure, documentation and labelling
- ISO 7176-16: Resistance to ignition of postural support devices
- ISO 7176-19: Wheeled mobility devices for use in motor
- ISO 7176-21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
Clinical Testing:
Clinical testing is not applicable.
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.
M300 & M400 (K103477)
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
§ 890.3860 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).
0
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 design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2015
Permobil AB Jan Åström Director Quality & Environment Per Uddens VAG 20, Timra, SE 86123 Vasternorrland SWEDEN
Re: K143180
Trade/Device Name: F3 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 10, 2015 Received: February 10, 2015
Dear Mr. Åström:
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. 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
1
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143180
Device Name F3 Powered Wheelchair
Indications for Use (Describe)
The intended use of the F3 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
| Type of Use (Select one or both, as applicable) | Exportation Use (Part 367.2(a) Category Five) Own-Use Consumption (Part 367.2(a) Category Six) | Exportation Use (Part 367.2(a) Category Five) | Own-Use Consumption (Part 367.2(a) Category Six) | ||
|---|---|---|---|---|---|
| Exportation Use (Part 367.2(a) Category Five) | |||||
| Own-Use Consumption (Part 367.2(a) Category Six) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: F3
510(k) Summarv
Submitter Permobil AB Box 120 S-861 23 Timrå Sweden
Phone: +46 60 595900 Facsimile: +46 60 575250
Contact Person: Jan Åström e-mail address: jan.astrom@permobil.se
Date Prepared: February, 2015
Trade name: F3
Common or Usual Name: Powered Wheelchair
Classification Name: Powered wheelchair
Product Code: ITI
Predicate Devices: M300 & M400 (K103477) manufactured by Permobil AB.
Intended use:
The intended use of the F3 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Description of device:
F3 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick.
The F3 is powered by two 12VDC 60Ah or tow 12VDC 73Ah. Group M34 batteries or Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive wheels with drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest.
When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.
Comparison to Predicate Devices:
The F3 is substantially equivalent to the M300 & M400 (#K103477). The F3 has the same intended uses and similar indications, technological characteristics and principles of operation. F3 has slightly more power than compared predicated device but no changes in speed occur. F3 has the same option in tilt, recline and elevation functions as the predicated device, see below table. These functions working in the same technological characteristics as the predicated M300 & M400.
4
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: F3
Image /page/4/Picture/1 description: The image shows the logo for Permobil. The word "permobil" is written in a bold, sans-serif font in blue color. Below the word "permobil" is the phrase "THE POWER OF MOBILITY" in a smaller, sans-serif font in black color.
| Functions | M300 & M400
Predicated device | F3
Submitted device |
|-----------|----------------------------------|------------------------|
| Tilt | X | X |
| Recline | X | X |
| Elevation | X | X |
The submitted device differs from the predicated device on its position of the drive wheel. The predicated device have a shorter turning radius and are less comfortable compared to a front driven chair because the placement of the tires on the chassis. A front wheel driven chair have a better obstacle climbing than a central driven chair. The submitted device are tested and having same or improved results as the already predicated device. These technological differences do not raise any new issues in safety and effectiveness.
Other specific differences between the F3 and the M300 & M400 (K103477) are:
-
- F3 has slightly larger pivoting caster wheels than the predicated device.
-
- Slightly specific dimensions such as height, length, weight and turning radius are different.
These minor technological differences between the F3 and its predicate device M300 & M400 raise no new issues of safety or effectiveness. Performance data demonstrates that the F3 is as safe and effective as the M300 & M400. Thus, the F3 is substantially equivalent.
Non-Clinical Testing:
The F3 complies to the below standards:
| Standard | Name | FDA recognized standards |
|---|---|---|
| ISO 7176-1 | Determination of static stability | 16-158 |
| ISO 7176-2 | Determination of dynamic stability of | |
| electric wheelchairs | 16-159 | |
| ISO 7176-3 | Determination of efficiency of brakes | 16-192 |
| ISO 7176-4 | Energy consumption of electric | |
| wheelchairs and scooters for determination | ||
| of theoretical distance range | 16-162 | |
| ISO 7176-5 | Determination of dimensions, mass and | |
| maneuverings space | 16-163 | |
| ISO 7176-6 | Determination of maximum speed, | |
| acceleration and deceleration of electric | ||
| wheelchairs | 16-29 | |
| ISO 7176-8 | Requirements and test methods for static, | |
| impact and fatigue strengths | - | |
| ISO 7176-9 | Climatic tests for electric wheelchairs | 16-167 |
| ISO 7176-10 | Determination of obstacle-climbing ability | |
| of electrically powered wheelchairs | 16-164 | |
| ISO 7176-11 | Test Dummies | 16-190 |
| ISO 7176-14 | Power and control systems for electrically | |
| powered wheelchairs and scooters - | ||
| Requirements and test methods | 16-165 | |
| ISO 7176-15 | Requirements for information disclosure, | |
| documentation and labelling | 16-27 | |
| ISO 7176-16 | Resistance to ignition of postural support | |
| devices | 16-191 | |
| ISO 7176-19 | Wheeled mobility devices for use in motor | - |
| ISO 7176-21 | Requirements and test methods for | |
| electromagnetic compatibility of electrically | ||
| powered wheelchairs and motorized | ||
| scooters | 16-166 |
5
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: F3
Image /page/5/Picture/1 description: The image shows the Permobil logo. The word "permobil" is written in blue, with the "o" in "mobil" being a circle. Below the word "permobil" is the phrase "THE POWER OF MOBILITY" in a smaller, black font.
Clinical Testing:
Clinical testing is not applicable.
Conclusions:
The F3 and the predicated device M300 & M400 are substantial equivalence. F3 has the same general intended use and similar indications, principles of operation, and similar technological characteristics as the previously cleared M300 & M400. The differences between the devices are minor and do not raise any new issues of safety and effectiveness because both devices have passed all necessary testing and are considered safe and effectives for use.