(118 days)
Not Found
Not Found
No
The summary describes a basic electric scooter with simple hand controls and does not mention any AI or ML capabilities.
No
The device is a scooter designed for mobility, not to treat or alleviate a medical condition.
No
The device description and intended use clearly state that the Model SE03 is an electric powered scooter designed to provide mobility, not to diagnose medical conditions.
No
The device description explicitly states "Electric Powered Scooter, Model SE03," indicating a physical hardware device.
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 adults. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as an "Electric Powered Scooter." This is a mobility aid.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are specifically designed to perform tests on samples from the human body to provide information about a person's health. The Model SE03 clearly falls outside of this category.
N/A
Intended Use / Indications for Use
The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.
Product codes
INI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
Sunpex Technology Company. I.TD. Leonard Frier c/o Met Laboratories, Inc. 914 West Patapsco Avenue Baltimore, Maryland 21230
Re: K033019
Trade/Device Name: Electric Powered Scooter, Model SE03 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-whecled vehicle Regulatory Class: II Product Code: INI Dated: December 26, 2003 Received: December 29. 2003
Dear Mr. Frier:
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 adultcration.
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 IDA's issuance of a substantial equivalence determination docs 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 Acts 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 – Mr. Leonard Frier
This letter will allow you to begin marketing your device as described in your Section 510/km 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 (301) 594-4659. 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.
sincerely yours.
Mark N. Millherson
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
2
Indications for Use Statement
510K number:
Device Name: Model SE03, Electric Power Scooter ·
Indications For Use: The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.
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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number Over-The-Counter Use_ Prescription Use______________________________________________________________________________________________________________________________________________________________ ાર