(147 days)
Not Found
No
The device description focuses on standard powered wheelchair components and control mechanisms (joystick, motor, brakes) and does not mention any AI/ML related terms or functionalities.
No.
The device is a powered wheelchair intended for mobility, not to treat or cure a medical condition.
No
The device description indicates that the "STREET powered wheelchair" is for mobility and is controlled by a joystick. There is no mention of it being used to diagnose medical conditions or analyze health data.
No
The device description clearly outlines a physical, hardware-based powered wheelchair with components like a frame, motors, batteries, and a joystick controller. It is not solely software.
Based on the provided information, 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.
- Device Description and Intended Use: The description clearly states the device is a "powered wheelchair" intended for "outdoor and indoor mobility to persons limited to a seated position." This is a mobility aid, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, or diagnostic testing.
Therefore, the Street Powered Wheelchair falls under the category of a mobility device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the STREET 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
Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of 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)
The STREET has in substantially the same intended usc and similar technological characteristics as the Quantum Blast. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the STREET device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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: STREET
JAN : 0 2004
Attachment 12
510(k) Summary
| Submitter | Permobil AB
Box 120
Årvältsvägen 10
S-861 23 Timrå
Sweden |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +46 60 595900 |
| Facsimile: | +46 60 575250 |
| Contact Person: | Bengt Persson |
| e-mail address: | bengt.persson@permobil.se |
| Date Prepared: | September 1, 2003 |
| Device name: | STREET |
| Classification Name: | Powered wheelchair |
| Predicate Devices: | Quantum Blast (K011993) manufactured by Pride Mobility. |
| Intended use: | The intended use of the STREET 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: | Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of 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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2004
Mr. Bengt Persson Director, Quality and Environment Permobil AB Box 120 Årvältsvägen 10 S-861 23 Timrå Sweden
Re: K032765
Trade/Device Name: STREET Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: December 2, 2003 Received: December 2, 2003
Dear Mr. Persson:
We have reviewed your Scction 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 Fedcral 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither 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 I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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.
2
Page 2 – Mr. Bengt Persson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter with and in you vo or substantial equivalence of your device to a legally premativer notification." The 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 if you desire specific as no as a moliance at (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under 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,
Sincerely yours,
Mark N. Millikan
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
3
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: STREET
Image /page/3/Picture/1 description: The image shows a black oval with the word "permbil" written in white letters inside. The letters are stylized and have a rounded appearance. The oval is surrounded by a thin white border.
Attachment 13
Indication for Use Statement
Substantial Equivalence
The product, which is substantially equivalent to this device, is Pride Mobility's Quantum Blast Rear Wheel Drive Power Wheclchair (K011993 July 13, 2000).
Safety and effectiveness
The STREET has in substantially the same intended usc and similar technological characteristics as the Quantum Blast. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the STREET device is substantially equivalent to the predicate device.
Indication for Use
The intended use is to provide indoor and outdoor mobility to persons restricted to a sitting position.
510(k) number
Not assigned at the writing of this submission
Device name
STREET
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR 801.109) □
or
Over the counter use
f Mark N Milkum
(SID)
neral, Restorative
Y
[e]'
I Devices
KO32
(Division Sign-Off) Division of General Restorative Devices
510(k) number