(63 days)
Not Found
No
The description focuses on standard powered wheelchair components and functionality, with no mention of AI/ML terms or capabilities like automated navigation, object detection, or adaptive control based on learned patterns.
No
The device, a powered wheelchair, is intended to provide mobility, which is assistive rather than therapeutic. Its function is to aid movement for individuals limited to a seated position, not to treat a medical condition or restore a bodily function.
No
The device is a powered wheelchair designed for mobility, not for detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly outlines a physical, battery-operated powered wheelchair with mechanical components (motors, gears, brakes, frame, wheels) and electrical components (batteries, motor controller). It is not solely software.
No, 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 mobility. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair, its components, and how it operates to move a person. It does not mention any analysis of biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
This device is a medical device that provides a therapeutic or assistive function (mobility), but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Model M powered wheelchair is to provide outdoor 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
The WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop.
The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (
§ 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Whill, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K153543
Trade/Device Name: Whill Model M Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 28, 2016 Received: January 29, 2016
Dear Mark Job:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (21 CFR 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,
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153543
Device Name WHILL Model M
Indications for Use (Describe)
The intended use of the Model M powered wheelchair is to provide outdoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5 510(k) Summary
| Submitter's Name: | WHILL, Inc. |
|---|---|
| Address: | 285 Old County Rd, Suite 6, San Carlos CA |
| Contact Person: | Terese Bogucki |
| Title: | Regulatory Consultant |
| Telephone Number: | 650-488-7799 |
| Fax Number: | 650-227-2264 |
| Email: | terri@decusbiomedical.com |
| Date Summary Prepared: | August 24, 2015 |
| Device Proprietary Name: | WHILL Model M Powered Wheelchair |
| Model Number: | Model M |
| Common Name: | Powered Wheelchair |
| Regulation Number: | 21 CFR 890.3860 |
| Product Code: | ITI |
| Device Class: | II |
Predicate Device
| Trade Device Name: | F3 Corpus |
|---|---|
| Manufacturer: | Permobil AB |
| Address: | Per Uddens Vag 20 Timra, SE 86123 Vasternorrland |
| Sweden | |
| Regulation Number: | 21 CFR 890.3860 |
| Regulation Name: | Wheelchair, Powered |
| Regulatory Class: | Class II |
| Product Code: | ITI |
| 510(k) Number: | 143180 |
| 510(k) Clearance Date: | March 27, 2015 |
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5.1 Description of the Device
The WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop.
The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (