JUSTWIN SCOOTER, MODEL JS-401

• K Number: K032277
• Device Name: JUSTWIN SCOOTER, MODEL JS-401
• Manufacturer: JOY RIDE TECH CO., LTD.
• Date Cleared: 2003-09-24 ( 63 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Description

Not Found

AI/ML Overview

The provided document regarding the Justwin Scooter, Model JS-401 (K032277), is an FDA 510(k) clearance letter. This type of document primarily addresses the substantial equivalence of a device to a predicate device, allowing it to be marketed. It does not typically contain the detailed information about acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a more comprehensive technical submission.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be extracted. The document is an FDA clearance letter based on substantial equivalence, not a performance report with detailed acceptance criteria or test results.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Cannot be extracted. The document does not describe any specific test set or study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Cannot be extracted. This information is not relevant to an FDA 510(k) clearance letter for a motorized scooter, which does not involve "ground truth" establishment in the context of diagnostic or interpretive tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Cannot be extracted. Not applicable to this type of device and document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Cannot be extracted. This is a medical device (motorized scooter), not an AI-powered diagnostic or assistive technology for human readers. An MRMC study is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Cannot be extracted. Not applicable, as this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Cannot be extracted. The concept of "ground truth" as typically used in the context of diagnostic or interpretive AI systems does not apply to a motorized scooter.

8. The sample size for the training set:

   • Cannot be extracted. A "training set" is not relevant for the type of documentation provided for this device.

9. How the ground truth for the training set was established:

   • Cannot be extracted. Not applicable.

What the document does tell us:

• Trade/Device Name: Justwin Scooter, Model JS-401
• Regulation Number: 21 CFR 890.3800
• Regulation Name: Motorized three-wheeled vehicle
• Regulatory Class: II
• Product Code: INI
• Intended Use: "The device is intended for medical purposes to provide mobility to persons restricted to a seated position."
• Basis for Clearance: Substantial equivalence to legally marketed predicate devices, meaning it has similar indications, technological characteristics, and safety and effectiveness profiles as a device already on the market. The FDA has "made a determination that the device is substantially equivalent... for the indications for use stated in the enclosure."

In summary, this document is an FDA approval letter for market clearance based on substantial equivalence, not a detailed technical report or study publication that would contain the specific performance metrics and study details requested.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle, there is a symbol consisting of three stylized human profiles facing to the right, arranged in a stacked formation.

Public Health Service

SEP 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Joy Ride Tech Co. Ltd. c/o Ms. Shu Chen Cheng ROC Chinese-European Industrial Research Society CEIRS 2064 Tamarin Drive Columbus, OH 43235

Re: K032277

Trade/Device Name: Justwin Scooter, Model JS-401 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 17, 2003 Received: July 23, 2003

Dear Ms. Cheng:

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.

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Page 2 - Ms. Shu Chen Cheng

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 [phone]. 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N Millerson

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

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JOY RIDE TECH CO., LTD.

No. 23. 3Rd Nan Kang Road. Nantou Taiwan ROC Tel: [phone] Fax: [phone] E-mail: [e-mail] http:// www.justwin.com.tw91030

B.1 INTENDED USE

The intended uses for the subject device and the predicate device are the same and it is

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Mark N Milken

Division Sign -Division of General, Restorative and Neurological Devices 632277

510(k) Number -

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).