(35 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Be-Mobile 3-wheeled Electric Scooter DK S320 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 enboard battery charger.
Here's a breakdown of the acceptance criteria and study information for the Be-Mobile 3-wheeled Electric Scooter, DK S320, based on the provided FDA 510(k) summary:
This device is not an AI/ML powered device, therefore, some of the requested information (like multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable and will be marked as N/A.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | Passed |
| CISPR 11: 1990 (Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement) | Passed |
| EN61000-3-2: 1995 (Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)) | Passed |
| IEC61000-3-3: 1995 (Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low voltage supply systems for equipment with rated current ≤ 16A per phase and not subject to conditional connection) | Passed |
| Substantial Equivalence to Predicate Device (WU`S 3-wheeled NEO SCOOTER WT-L3 (K023040)) | Achieved (Electronic systems are the same and UL certificated, ensuring the same safety level. Differences in controller, overall dimensions, tire size, and weight are noted but deemed not to affect safety.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical trials or data for performance evaluation in the way AI/ML devices typically would. The performance testing refers to engineering standards applied to the device itself.
- Sample Size for Test Set: N/A (Performance testing was conducted on the device, not a distinct "test set" of patient data.)
- Data Provenance: N/A (The testing relates to product compliance with engineering standards, not patient data.)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. Ground truth in this context refers to compliance with established engineering and safety standards, which are verified through defined test procedures. It doesn't involve expert medical interpretation of data.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of medical images or data. For engineering standards, the outcome is pass/fail based on objective measurements against the standard's criteria.
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
N/A. This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is compliance with established international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3). The "performance testing" section indicates that the device "passed" these standards. Additionally, the basis for clearance is substantial equivalence to an existing legally marketed predicate device (WU`S 3-wheeled NEO SCOOTER WT-L3).
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established
N/A. This is not an AI/ML device.
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K033241 1/2
September 29, 2003
Image /page/0/Picture/1 description: The image shows the text "DK CITY" in a stylized font. The letters "DK" are in a bold, sans-serif font, while "CITY" is in a cursive font. There is a design element between "DK" and "CITY" that resembles angled brackets. The text is black against a white background.
TUNG KENG ENTERPRISE CO., LTD. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.net
NOV 1 0 2003
6 é 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 S320
Electrical Scooter Motor Three-Wheeled Venicle, 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 S320 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 enboard 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: WU`S 3-wheelED NEO SCOOTER WT-L3 (K023040)
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K033241 2/2
DK(C/T)
TUNG KENG ENTERPRISE CO., LTD. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-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. Thus the same safety level for the two devices is assured. The major differences existing of the two 3-wheelled scooters are the different controller. That means the new device, DK S320, use Dynamic Rhino DS72k controller, and the predicate device, WT-L3, use Curtis PMC controller. 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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with three parallel lines above them, resembling flowing hair or a symbolic representation of health and human services.
NOV 1 0 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: K033241
Trade/Device Name: Be-Mobile 4 Wheeled Electric Scooter, DK S320 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 29, 2003 Received: October 6, 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. Iisting 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 - 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
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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Page 1 of 1
510 (K) NUMBER ( IF KNOW ): _ TBA
DEVICE NAME: Be-Mobile 3-Wheeled Electric Scooter, DK S320
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted o a siting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
OR
Prescription Use
Over -- The -- Counter -- Use
( Per 21 CFR 801.109 )
( Optional Format 1-2-96 )
Miriam C. Provost
(Division Sign Off)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number Ko33241
、その後の時間を行って、不用の行動になっていると、
FI
§ 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).