(28 days)
Not Found
No
The summary describes a standard mobility scooter with mechanical controls and battery operation, with no mention of AI or ML features.
No
This device is a mobility aid used for transportation, not for treating a medical condition.
No
The device description clearly states its purpose is for transportation and mobility, not for diagnosing any medical conditions.
No
The device description clearly states it is a battery-operated scooter with a tiller handle and throttle control, indicating it is a physical hardware device, not software only.
Based on the provided information, the Proasia L4501 scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to disabled or elderly persons. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a battery-operated transportation vehicle controlled by a tiller and throttle. This aligns with a mobility aid, not a device used for in vitro testing.
- Lack of IVD Characteristics: 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 those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the Proasia L4501 scooter is a mobility device, not an IVD.
N/A
Intended Use / Indications for Use
The Proasia L4501 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The Proasia L4501 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Product codes
89INI
Device Description
The Proasia L4501 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bewell SC 20 (K043326)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
OCT 7 - 2005
Image /page/0/Picture/1 description: The image shows the word "Proasia" in a bold, sans-serif font. The letters are closely spaced together, creating a compact and solid appearance. The color of the text is black, contrasting with the white background.
2/F, Block 3, Wah Lai Industrial Centre, 10-14 Kwei Tei Street, Fo Tan, Shatin, New Territories, Hong Kong website:http://www.perfect-group.com/ TEL: + 852-26911863 FAX: + 852-26930358
510(k) Summary
Device
Trade name: Proasia L4501 scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device
Proasia L4501 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The Proasia L4501 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The Proasia L4501 scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.
There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Proasia Limited believes that the Proasia L4501 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement around the symbol. The symbol is composed of three abstract human figures, each represented by a single, continuous line.
Public Health Service
OC1 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jeff Chang Proasia Limited 16F .- 2, No. 462 Sec. 2, Chong-De Road Beitun District, Taichung China (Taiwan) 40653
Re: K052486
Trade/Device Name: Proasia L4501 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 1, 2005 Received: September 9, 2005
Dear Mr. Chang:
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.
2
Page 2 - Jeff Chang
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 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,
Mark N. Melkerson
- Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): _(