(68 days)
No
The description focuses on standard powered wheelchair technology with hand controls and a braking mechanism, with no mention of AI or ML.
No
Explanation: The device, a powered wheelchair, is intended to provide mobility, which assists with daily living activities rather than treating or diagnosing a medical condition.
No
The device description indicates it is a powered wheelchair for mobility, not to diagnose a condition.
No
The device description clearly outlines a physical, battery-operated wheelchair with a frame, wheels, seat, armrests, seat belt, and hand controls. It references existing hardware components and predicate devices that are also physical wheelchairs.
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 persons restricted to a seated position or who are mobility impaired." This is a functional purpose related to physical assistance and mobility, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details a powered wheelchair with mechanical and electrical components for movement and control. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a Powered Wheelchair, which falls under a different regulatory category than IVDs. The predicate devices listed (K011687 Merits Powered Wheelchair) also confirm its classification as a mobility aid.
N/A
Intended Use / Indications for Use
The device is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
Product codes
ITI
Device Description
The Rascal "We Go 250" Powered Wheelchair is an indoor/outdoor use battery operated wheelchair. It has a frame with four (4) wheels, a seat, two (2) arm rests and a seat belt. The primary technology advantage of this device is that the movement of the wheelchair can be controlled by the rider or an attendant using hand controls located at the top of steering column to adjust the speed and direction of the wheelchair with occupant therein. These hand controls for the attendant are the same controls used for most electric scooters (Motorized Three Wheeled Vehicles - Regulation Number 890.3800). We currently market electric scooters with that same technology (510k K002616). The brake mechanism is activated or deactivated dependant upon the use of the hand controls located at the top of the steering column.
The base of the wheelchair is same base currently used on 510k approved device (K013788)
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
An extensive collection of tests has been conducted and successfully completed, including all testing in accordance with FDA Recognized Consensus Standards for Powered Wheelchairs. Product Code ITI, Regulation Number 890-3860. All testing indicates that the Rascal "We Go 250" meets its performance requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
SEP 2 1 2009 1 :
510(k) Submission Summary - "We Go 250" Powered Wheelchair
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness of the Rascal "We Go 250".
Submitter's Name: Electric Mobility (d.b.a. The Rascal Company) 591 Mantua Blvd., Sewell NJ 08080 FDA Registration Number: 3005191512 Owner/Operation Number: 2244608 Official Contact: Steve Beversluis - Director of OA/Regulatory
Date Summary Prepared: July 6, 2009
- Device Identification:
Proprietary Name: Rascal "We Go 250" Generic Name: Powered Wheelchair Predicate Device: Merits Powered Wheelchair K011687 Classification of Predicate Device: Powered Wheelchair, Class II 21 CFR 890.3860 Product Code: ITI Classification Name: Powered Wheelchair, Class II 21 CFR 890.3860
- Intended Use:
The device is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
3. Device Description:
The Rascal "We Go 250" Powered Wheelchair is an indoor/outdoor use battery operated wheelchair. It has a frame with four (4) wheels, a seat, two (2) arm rests and a seat belt. The primary technology advantage of this device is that the movement of the wheelchair can be controlled by the rider or an attendant using hand controls located at the top of steering column to adjust the speed and direction of the wheelchair with occupant therein. These hand controls for the attendant are the same controls used for most electric scooters (Motorized Three Wheeled Vehicles - Regulation Number 890.3800). We currently market electric scooters with that same technology (510k K002616). The brake mechanism is activated or deactivated dependant upon the use of the hand controls located at the top of the steering column.
The base of the wheelchair is same base currently used on 510k approved device (K013788)
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4. Predicate Device:
The Rascal Company believes that the Rascal "We Go 250" is substantially equivalent to the following predicate device:
Merits Health Products Company Ltd. K011687
5. Technological Characteristics:
This device has the same intended use as the legally marketed device(s), as shown in the substantial equivalence table, with technological characteristics that do not raise questions on the safety and effectiveness during use.
6. Performance Testing:
An extensive collection of tests has been conducted and successfully completed, including all testing in accordance with FDA Recognized Consensus Standards for Powered Wheelchairs. Product Code ITI, Regulation Number 890-3860. All testing indicates that the Rascal "We Go 250" meets its performance requirements.
7. Conclusion:
The Rascal "We Go 250" Powered Wheelchair has the same intended use and similar technological characteristics as the legally marketing device Merits Powered Wheelchair Moreover, the non-clinical testing and the predicate comparisons MP3 (P320). demonstrate that any differences in their technological characteristics do not raise any questions as to safety and effectiveness. Thus, the Rascal "We Go 250" is substantially equivalent to the predicate device.
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Image /page/2/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. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 1 2009
Electric Mobility Corporation % Mr. W. Stephen Beversluis Director of Quality/Regulatory 1 Mobility Plaza Sewell, New Jersey 08080
Re: K092130
Trade/Device Name: Rascal "We Go 250" Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 6. 2009 Received: July 15, 2009
Dear Mr. Beversluis:
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. W. Stephen Beversluis
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510k Number: _________________________________________________________________________________________________________________________________________________________________
Device Name: Rascal "We Go 250" Powered Wheelchair
Indications for Use:
The Rascal "We Go 250" Powered Wheelchair is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
Prescription Use _ × (Per 21 CFR 801 Subpart D) and/or
Over-The Counter Use _ X (Per 21 CFR 801 Subpart C)
Please do not write below this Line – Continue on another Page, IF Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Of (Division Sign-cical, Orthopedic, and Restorative Devices
510(k) Number K092130