(13 days)
Not Found
No
The description focuses on basic mechanical and electrical components and control via hand controls, with no mention of AI/ML terms or functionalities.
No
The device provides mobility assistance, which is a supportive function, but it does not treat or cure a disease or condition. Its purpose is to compensate for a limitation, not to therapeutically intervene.
No
The device description indicates it is an electric scooter for mobility, and the intended use states it is to "provide mobility to persons restricted to a seated position." There is no mention of it being used to diagnose any medical condition, nor does it process any diagnostic data.
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.
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 an electric scooter for mobility, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device described is a mobility aid, which falls under a different category of medical devices than IVDs.
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-E'V415 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 c in 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/V ɔl.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers -- requirements and test met hods)
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 29, 2006
OMFORT OCT 1 6 2006 OMFORT ORTHOPEDIC CC., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei SI ang Shiang,Chia-yi,Taiwan,R.O.C.608 TEL : 886-5-2892093 FAX : 886-5-2890070
દર 510(I:) SUMMARY "
Submitter's Name: COMFORT ORTHOPEI›IC CO., LTD.
N0. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, TAIWAN, ROC
Date summary prepared:
Device Name:
Proprietary Name: COMFORT SCOOTER, LY-EW415 Common or Usual Name: Electric Scooter Classification Name: Motor zed 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-E'V415 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 c in be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/V ɔl.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers -- requirements and test met hods)
Legally marketed device for substantial equivilence comparison: COMFORT WINDJOY SCOOTER LY-EW302 (K022369)
1
COMFORT COMFORT 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
C.1 SUMMARY TABLE
| ITEMS | SUBJECT DEVICE | PREDICATE
DEVICE 1 |
|---------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| BRAND NAME | COMFORT | COMFORT |
| MANUFACTURER | COMFORT | COMFORT |
| SERIES | FUTURE | WINDJOY |
| MODEL NO | LY-EW415 | LY-EW302 |
| 510K NO | TBA | K022369 |
| INTENDED USE | SAME | The device is
intended for
medical
purposes to
provide mobility
to persons
restricted to a
seated position. |
| Overall dimension | | |
| Overall length | 59.8" / 152 cm | 48" |
| Overall width | 28.3" / 72 cm | 24.4" |
| Max loading | 180 kgs / 400 lbs | 265 lbs |
| Electronics | SAME | Dynamic
Rhino series |
| Batteries | | |
| Quantity | Two | Two |
| Type | Sealed lead acid, 75Ah
12VDC | Sealed lead acid, 40Ah
12VDC |
| Range per charge | 75 km / 46.8 miles | 28 miles |
| ITEMS | SUBJECT DEVICE | PREDICATE
DEVICE 1 |
| Front tires | 4.00-5 (pneumatic) | 85 x 260 mm |
| Rear tires | 3.00-10 (pneumatic) | 4.10 / 3.50-5" |
| Maximum speed | 8 km / 5.0 mph | 5.5 mph |
| Turning radius | 180 cm / 70.8" | 43.3" |
| Back upholstery | SAME | Fabric |
| Scooter weight | 140 kgs / 308 lbs
( with battery ) | 165 lbs
( w/o battery ) |
| RECHARGER | DC 24V 8A
Remote | DC 24V 5A
Remote |
| Safe climbing angle | SAME | 12° |
| Warranty | | |
| 3 years | SAME | Main frame |
| 1 year | | Controller / gear motor
main components w/o
exhaustive and wear part |
C1
2
COMFORT 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
3
OMFORT COMFORT 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
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
The overall dimensions and visional appearance are similar, and the dimensions for the new device are larger than that of the predicate device. The device of the smaller dimensions can be fitted into most of the ordinary car trunk. Our new device may not be fitted into small car trunk, but this is NOT related to the safe aspect. Besides, a device of larger dimensions can hold more mass and possess more balance. It certainly has more safety during moving and turning.
The batteries used are same supplier and they are certificated by UL. The control systems for the two devices are same supplier; it is Dynamic Rhino series controller types for the two devices. The recharge for the two devices are also used the same resource and they are certified by UL. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.
The maximum speed is 0.5 mph difference for the two devices. The throttle tiller can continuously adjust the speeds. The operators can set the adequate speed according to their feeling and need, i.e., outdoor or indoor, and the maximum speed differences do not mean any performance differences. The new device has lower maximum speed, thus leading to more safety and less hazard. They are substantially equivalent.
The battery chargers types are almost the same; only for the output electric current is 8A for the new device and 5A for the predicate device. The current differences lead to the charging period differences or arise from the different battery capacity, not related with safety aspect.
Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Public Health Service
OCT 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Comfort Orthopedic Co., Ltd. % Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, China (Taiwan) 30067
Re: K063032
Trade/Device Name: Comfort Scooter, LY-EW415 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. Ke-Min:
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.
5
Page 2 - Dr. Jen Ke-Min
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 vours.
Morgan Buckner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510 (K) Number ( If Known ):_ र
Device Name: COMFORT SCOOTER, LY-EW415
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use √
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Malvare Buellin
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-On) Division of General, Restorative, and Neurological Devices
510(k) Number K063037
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