(20 days)
No
The description focuses on the mechanical and electrical components of a standard powered scooter and does not mention any AI or ML capabilities. The performance studies listed are related to electrical and mechanical safety standards, not algorithmic performance.
No
Explanation: The device is a mobility aid (scooter) for individuals with restricted mobility, not a device used to treat or cure a medical condition.
No
Explanation: The device description states its intended use is for "medical purposes to provide mobility to persons restricted to a seated position." There is no mention of it being used to diagnose conditions.
No
The device description clearly describes a physical electric scooter with hardware components like wheels, a seat, armrests, a basket, and hand controls, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a powered scooter, which is a mobility aid. 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 the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a mobility device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes
INI
Device Description
The KING I Powered Scooter, CTL-11 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front The movement of the scooter is controlled by the rider who uses hand basket. controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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)
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WU'S 3-WHEELED NEO SCOOTER WT-T3D (K032488)
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
Image /page/0/Picture/0 description: The image shows a logo with a cartoon bird on the left and the word "KINGI" in bold letters. Above the word "KINGI" is the date "OCT 17 2005". The cartoon bird is facing left and has a small drop of water coming off of its wing. The word "KINGI" is underlined.
K 052673
#65 Chyau-Shiaw St., Pei-Tun District. Taichung, Taiwan, R.O.C. Tel: 04 2244 5815 Fax: 04 2244 0700
દ ૯ 510(k) SUMMARY "
Submitter's Name: KING I Tech Corporation
No. 65, Chyau-Shiaw Street, Pei-Tun Area, Taichung City, 408, Taiwan
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
September 22, 2005
KING I Powered Scooter, CTL-11 Electrical Scooter Motor Three-Wheeled Vehicle, Class II, 21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The KING I Powered Scooter, CTL-11 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front The movement of the scooter is controlled by the rider who uses hand basket. controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: WU'S 3-WHEELED NEO SCOOTER WT-T3D (K032488)
1
Image /page/1/Picture/0 description: The image shows a cartoon bird next to the word "KINGI". The bird is drawn in black and white and has a large beak and small eyes. The word "KINGI" is written in bold, black letters, with a line underneath it. The image is simple and likely used as a logo or branding element.
Summary for substantial equivalence comparison:
The intended uses, weight limit, and back upholstery between the new device CTL-11 and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.
The major difference existing for the predicate device is more agile and easy to fold for storage or transportation and the new device is for general use. The new device needs drive bigger turning radius. Besides, the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
King I Tech Corporation c/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan, ROC China
Re: K052673
Trade/Device Name: KING I POWERED SCOOTER CTL-11 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 22, 2005 Received: September 27, 2005
Dear Dr. Jen:
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 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 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.
3
Page 2 - Ke-Min Jen, Ph.D.
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/industry/support/index.html
Sincerely yours,
squiggle
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a cartoon bird next to the word "KING I". The bird is drawn in black and white and has a large beak and round eyes. The word "KING I" is written in bold, black letters. The letter "I" is underlined.
#65 Chyau-Shiaw St., Pei-Tun District. Taichung, Taiwan, R.O.C. Tel: 04 2244 5815 Fax: 04 2244 0700
ं।
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: KING I, POWERED SCOOTER CTL-11
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | V |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED) (Division Signo Off)RH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number_________________________________________________________________________________________________________________________________________________________________