(73 days)
No
The device description and performance studies focus on the mechanical and electrical aspects of an electric scooter, with no mention of AI or ML technologies.
No.
The device provides mobility assistance, which is not considered a therapeutic function that changes or corrects a physiological state or condition.
No
Explanation: The device description clearly states its purpose is to provide mobility. There is no mention of it being used to diagnose medical conditions or analyze health data.
No
The device description clearly describes a physical electric scooter with hardware components (wheels, seat, battery, hand controls, steering column). It is not solely software.
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." This describes a device used for physical support and transportation, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details an electric scooter with wheels, a seat, and hand controls. This aligns with a mobility aid, not an IVD.
- 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.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly a mobility device, as further supported by the predicate device which is also a 3-wheeled scooter.
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 Be-Mobile 3-wheeled Electric Scooter DK S200 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand 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, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods). The electronic systems between two devices are the same 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
TUNG KENG ENTERPRISE No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang ichung County, Taiwan +886-4-25321000 Fax: +886-4-25325000 -mail: dkcity@ms21.hinte.net
દ્ધ 510(k) SUMMARY "
Submitter's Name: TUNG KENG Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, 427,Taiwan
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
Be-Mobile 3-wheeled Electric Scooter, DK S200 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 Be-Mobile 3-wheeled Electric Scooter DK S200 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand 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, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: J.D. 3-wheeled SCOOTER ES-350 (K022518)
September 29, 2003
1
UNG KENG ENTERPRISE CO 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang chung County, Taiwan +886-4-25321000 Fax: +886-4-25325000 mail: dkcity@ms21.hinte.net
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same 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 differences existing of the two 3-wheelled scooters are different overall dimensions, and the dimensions for the new device are smaller than those of the predicate device. Thus the new device needs smaller the overall dimension, weight limit, and the scooter weights are differences between the two devices. The new device, DK S200, of the smaller dimensions can be fitted into most of the ordinary car trunk, and this is NOT related to the safe aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
DEC 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tung Keng Enterprise Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K033240
Trade/Device Name: Be-Mobile 3 Wheeled Electric Scooter, DK S200 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: November 18, 2003 Received: November 25, 2003
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 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.
3
Page 2 - Dr. Ke - Min Jen
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 (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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
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
4
Page__________________________________________________________________________________________________________________________________________________________________________
510 (K) NUMBER ( IF KNOW ): _ K 033240
DEVICE NAME: Be-Mobile 3-Wheeled Electric Scooter, DK S200
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over - The - Counter - Use V AND/OR
(Part 21 CFR 801 Subpart D )
(21 CFR 807 Subpart C )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE )
** Restorative Devices