(86 days)
Not Found
No
The device description details a standard powered wheelchair controlled by a joystick and a basic controller, with no mention of AI or ML capabilities.
No
The device is a powered wheelchair designed for mobility, not to treat or cure a medical condition.
No
The device description clearly states it is a "powered wheelchair" intended for "outdoor and indoor mobility." There is no mention of it being used to diagnose any medical condition, nor does its functionality (joystick control, motor-driven, braking) suggest a diagnostic purpose.
No
The device description clearly outlines numerous hardware components including a frame, wheels, motors, batteries, a controller, and a joystick, indicating it is a physical device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The provided description clearly states that the C350 is a powered wheelchair designed to provide mobility to individuals. It describes its mechanical and electrical components, how it's controlled, and its function in assisting with movement.
- Intended Use: The intended use is explicitly stated as providing "outdoor and indoor mobility to persons limited to a seated position." This is a functional mobility aid, not a diagnostic tool.
The description of the C350 aligns with a Class II medical device (specifically a powered wheelchair), which is regulated by the FDA but is not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the C350 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
ITI
Device Description
C350 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair VR-2 70 amp controller. The user interface is a joystick. The C350 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 22 km (13.75 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users 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 direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user 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)
In all instances, the C350 functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
C300(Electro)(K041219)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: C350
Image /page/0/Picture/2 description: The image shows the logo for Permobil. The logo is an oval shape with the word "permobil" written in lowercase letters inside. The word is in a bold, sans-serif font. The background of the oval is textured.
Attachment 11
510(k) Summary
SEP 1 2 2007
| 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: | June, 2007 |
| Device name: | C350 |
| Classification Name: | Powered wheelchair |
| Predicate Devices: | C300(Electro)(K041219) manufactured by Permobil AB. |
| Intended use: | The intended use of the C350 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: | C350 Powered Wheelchair is battery powered, rear wheel motor driven and
is controlled by the PG power wheelchair VR-2 70 amp controller.
The user interface is a joystick.
The C350 is powered by two 12VDC 60Ah, Group M34 batteries,
approximate driving range on fully charged batteries is up to 22 km (13.75
miles), depending on use and the terrain the chair is driven on.
The chair frame is a rived nut and welded steel construction and includes
two rear drive wheels with drive units (motor, gear, brake), batteries and
front pivoting casters.
Depending on users 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 direction the
joystick is actuated.
When the user releases the joystick, the chair slows to a stop and the brakes
are automatically re-engaged. The solenoid electromechanical brakes allow
the user stop by letting go of the joystick. |
1
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: C350
Image /page/1/Picture/1 description: The image shows the word "permobil" in a stylized font. The word is in black and is surrounded by a black oval. The background of the oval is a textured gray color.
Performance Data
In all instances, the C350 functioned as intended.
Substantial Equivalence
The C350 is substantially equivalent to the C300(Electro) (#K041219). The C350 has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the C350 is as safe and effective as the C300(Electro). Thus, the C350 is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Permobil AB % Mr. Jan Astrom Quality Engineer Box 120 S-861 23 Timra Sweden
SEP 1 2 2007
Re: K071650 Trade/Device Name: Powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 9, 2007 Received: August 17, 2007
Dear Mr. Astrom:
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.
3
Page 2 - Mr. Jan Astrom
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely v
Fn Dbl
Mark N. Melkerson
Director
Drp D.n
4/11/08
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 12
INDICATION FOR USE
510(k) number Not assigned at the writing of this submission.
Device name: C350
Indication for Use
The intended use of the C350 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
Prescription use __
or
Over the counter use __
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K071650