(62 days)
Not Found
No
The device description and performance testing focus on standard electric scooter functionality and safety standards, with no mention of AI or ML.
No
The device is described as an electric scooter intended for mobility, which is assistive rather than therapeutic in nature. While it aids persons restricted to a seated position, its primary function is not to treat or alleviate a medical condition.
No
The device description indicates its purpose is to provide mobility, and the "Intended Use / Indications for Use" section states it "is intended for medical purposes to provide mobility to persons restricted to a seated position." There is no mention of diagnosing any condition or disease.
No
The device description clearly states it is an "indoor / outdoor Electric Scooter" with a physical base, wheels, seat, and hand controls, indicating it is a 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 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 physical mobility device (an electric scooter) with wheels, a seat, and controls. 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
- Diagnosing diseases or conditions based on sample analysis
- Using reagents or assays
The performance studies mentioned (EMC Report, ANSI / RESNA standards) are related to the electrical and mechanical safety and performance of a mobility device, not the analytical performance of a diagnostic test.
Therefore, the COMFORT SCOOTER, LY-EW406 is a mobility aid, not an In Vitro Diagnostic device.
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 COMFORT SCOOTER, LY-EW406 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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, controller, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
COMFORT AGILE SCOOTER LY-EW303 (K022369)
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
K063030
Page 1 of 2
MFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No. 120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi,Taiwan,R.O.C.608 TEL : 886-5-2892093 FAX : 886-5-2890070
66 510(k) SUMMARY "
DEC = 4 2006
September 29, 2006
Submitter's Name: COMFORT ORTHOPEDIC CO., LTD.
N0. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, TAIWAN, ROC
Date summary prepared:
Device Name:
Proprietary Name: COMFORT SCOOTER, LY-EW406 Common or Usual Name: Electric Scooter Classification Name: Motorized 3-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 COMFORT SCOOTER, LY-EW406 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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, controller, and their chargers - requirements and test methods)
. _ Legally marketed device for substantial equivalence comparison: COMFORT AGILE SCOOTER LY-EW303 (K022369)
1
K063030
Page 2 of 2
OMFORT MFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No. 120, Nan Shiang Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R. O. C. 608 TEL : 886-5-2892093 FAX : 886-5-2890070
Summary for substantial equivalence comparison:
The intended uses, the load weight limit 265 lbs, electronic controller, back upholstery and armrest types, and warranty period between the new device LY-EW303 and the predicate device LY-EW302 are the same. Especially the electronic controller and recharge between two devices are all passed by the UL certificated. Thus the same safety level for the two devices is assured.
The major difference existing is the new device is more agile than the predicate device. 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.
The maximum speed is 4.2 mph for the new device and 4.0 mph for the predicate device that are also under the 6 miles maximum speed limited. Those speeds can be continuous adjusted by the throttle tiller. The operators can set the adequate speed according to their feeling and need, and the maximum speed differences do not mean any performance differences. They are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Comfort Orthopedic Co., Ltd. % Dr. Ki-Men Jen Roc Chinese European Industrial Research Society No. 120, Nan Shiange Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R.O.C. 608
DEC - 4 2006
Re: K063030
Trade/Device Name: Comfort Scooter, LY-EW406 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 29, 2006 Received: October 3, 2006
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. Jen Ki-Men
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Plok Dep Director
Mark N. Melkerso 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 the logo and contact information for Comfort Orthopedic Co., LTD. The company's website is listed as www.comfort.com.tw. The address is No. 120, Nan Shiang Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R.O.C.608. The telephone number is 886-5-2892093, and the fax number is 886-5-2890070.
Indications for Use
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
Device Name: COMFORT SCOOTER, LY-EW406
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 |
| (21 CFR Part 807 Subpart C) |
ver-The-Counter Use
ಿ ಕ
(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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K063030 |
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