(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 technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a powered wheelchair designed for mobility, not to treat or cure a medical condition.
No
The provided text describes a powered wheelchair, which is a mobility device. Its intended use is to provide mobility to individuals, not to diagnose any medical condition. There is no mention of it being used to detect, monitor, or analyze any physiological parameters.
No
The device description clearly outlines hardware components such as a frame, motors, batteries, wheels, casters, and a joystick, indicating it is a physical device with integrated software for control.
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 mobility. 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 and control. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
- Use in a laboratory or clinical setting for diagnostic purposes
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the ELECTRO powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the Electro 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.
Product codes
ITI
Device Description
Electro Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VSI 70 amp controller.
The user interface is a joystick.
The Electro is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25 km (16 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 front drive wheels with drive units (motor, gear, brake), batteries and back 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
To provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
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 Electro functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Chairman 2k (1280) (K991658)
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 WHEELCHÁIR: ELECTRO
Image /page/0/Picture/1 description: The image shows the text "KO4-12-19" at the top. Below the text is a dark oval shape. Inside the oval shape is some text that is difficult to read due to the image quality. The text inside the oval appears to be a brand name or product name.
AUG - 4 2004
Attachment 11
510(k) Summary
| 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: | April 29, 2004 |
| Device name: | ELECTRO |
| Classification Name: | Powered wheelchair |
| Predicate Devices: | Chairman 2k (1280) (K991658) manufactured by Permobil AB. |
| Intended use: | The intended use of the ELECTRO 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: | Electro Powered Wheelchair is battery powered, front wheel motor driven
and is controlled by the PG power wheelchair VSI 70 amp controller.
The user interface is a joystick.
The Electro is powered by two 12VDC 60Ah, Group M34 batteries,
approximate driving range on fully charged batteries is up to 25 km (16
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 front drive wheels with drive units (motor, gear, brake), batteries and
back 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: ELECTRO
Image /page/1/Picture/1 description: The image shows a dark oval shape with some text inside. The text is difficult to read due to the image quality, but it appears to be a word or phrase. The oval shape is the dominant feature of the image, taking up most of the space.
Performance Data
In all instances, the Electro functioned as intended.
Substantial Equivalence
The Electro is substantially equivalent to the Chairman 2K (#K991658). The File Electro 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 Electro is as safe and effective as the Chairman 2K. Thus, the Electro is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2004
Mr. Jan Astrom Quality Engineer Permobil AB Box 120 S-861 23 Timra Sweden
Re: K041219 Trade/Device Name: Electro Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 24, 2004 Received: May 28, 2004
Dear Mr. Astrom:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 31 (x), pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prox to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices mat have occh receitsomed in assee approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The You may, therefore, thanket the devices, books requirements for annual registration, listing of gencial controls provisions of ractice, 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 is classified (600 world) als. Existing major regulations affecting your device can thay be subject to suell additional controller Listing of the 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr I S issuants over device complies with other requirements of the Act that I DA has made a doter regulations administered by other Federal agencies. You must of any i cacal statutes and regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to ough manieing of substantial equivalence of your device to a legally prematics notification: The PDF intelligestion 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 acries is. J 301) 594-4659. Also, please note the regulation entitled, Contact the Oriece of Compunited in (21CFR Part 807.97). You may obtain Misolanung of reference to premainters in 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.
Mih. A. Millers
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
4
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: ELECTRO
Image /page/4/Picture/1 description: The image shows the word "permobil" in a stylized font. The word is contained within a black oval shape. The letters are also black, but they are slightly lighter than the oval shape. The image has a grainy texture.
Attachment 12
INDICATION FOR USE
510(k) number K041219
Device name: Electro
Indication for Use
The intended use of the Electro 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 (Part 21 CFR 801 Subpart D)
or
Over the counter use (Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mud. N. Millkin
Division of General, Restorative, and Neurological Devices
510(k) Number K041219