(41 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard mobility scooter and does not mention any AI or ML capabilities.
No
The device is described as an electric scooter for mobility, not for treating a disease or condition. While it aids individuals restricted to a seated position, it does not provide therapy in the medical sense.
No
The device is described as an electric scooter for mobility, not for diagnosing medical conditions. Its intended use is to "provide mobility to persons restrict to a seated position."
No
The device description clearly states it is an "indoor / outdoor electric scooter" with a "base with four-wheeled with a seat" and "hand controls," indicating it is 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 clearly states the device is for "medical purposes to provide mobility to persons restrict to a seated position." This describes a device used on a person for a physical function (mobility), not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details an "indoor / outdoor electric scooter" with wheels, a seat, and hand controls. This is consistent with a mobility aid, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, assays, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a mobility aid, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restrict to a seated position.
Product codes
INI
Device Description
The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl is battery operated. It has a base with four-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)
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)
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
September 28, 2003
NOV 1 2 2003
EMG TECHNOLOGY CO. LTD.
No. 12-1,Lane 267, Sec. 3, Min Sheng Road, Taya Hsiang, Taichung Hsien, 428, Taiwan, ROC Telephone: 886-4-25684040 Fax: 886-4-25684038 E-mail: emg.tech(@msa.hinrt.net
46 510(k) SUMMARY "
Submitter's Name: EMG Technology Co., Ltd.
No. 12-1, Lane 267, Sec. 3, Min Sheng Road, Taya Hsiang, Taichung Hsien, 428, Taiwan, ROC
Date summary prepared:
Device Name:
| Proprietary Name: | ESG 4-WHEEL SCOOTER, ESG-03 |
|---|---|
| Common or Usual Name: | Electrical Scooter |
| Classification Name: | 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 restrict to a seated position.
Description of the device:
The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl is battery operated. It has a base with four-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: WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)
, s
1
EMG TECHNOLOGY CO. LTD.
No. 12-1,Lane 267, Sec. 3, Min Sheng Road, Taya Hsiang, Taichung Hsien, 428, Taiwan, ROC Telephone: 886-4-25684040 Fax: 886-4-25684038 E-mail: emg.tech@msa.hinrt.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 4-wheelled scooters are the different controller, and the new device, ESG-03, is more agile and easy to storage or transportation and the predicate device. WT-L4, is for general use. 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 U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
EMG Technology 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: K033204
Trade/Device Name: ESG 4-Wheeled Scooter, ESG-03 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 8, 2003 Received: October 20, 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-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 A. Milliman
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: ESG 4-Wheel Scooter ESG-03_
INDICATIONS FOR USE:
The device is intended for medical parposes to provide mobility to persons restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | |
|---|---|
| OR | |
| Over - The -- Counter -- Use | ✓ |
( Per 21 CFR 801.109 ) (Optional Format 1-2-96 )
(Division Sign-Off)
Division of General Restorative
and Neurological Devices
| 510(k) Number | K033204 |
|---|---|
| --------------- | --------- |
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