COMFORT SCOOTER, MODEL LY-EW415

K063032 · Comfort Orthopedic Co., Ltd. · INI · Oct 16, 2006 · Physical Medicine

Device Facts

• Record ID: K063032
• Device Name: COMFORT SCOOTER, MODEL LY-EW415
• Applicant: Comfort Orthopedic Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Story

Battery-operated, 4-wheeled indoor/outdoor electric scooter; provides mobility for individuals restricted to seated position. Rider operates device via hand controls on steering column. Features include adjustable speed throttle, disassembly capability for transport, and onboard battery charger. Used in various environments by the patient. Output is physical mobility; healthcare provider uses device to facilitate patient independence. Benefits include improved mobility and balance due to larger dimensions compared to predicate.

Clinical Evidence

Bench testing only. Compliance with ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995 for electrically powered wheelchairs, controllers, and chargers. Back upholstery passed resistance ignition test by SGS.

Technological Characteristics

Motorized 4-wheeled vehicle; battery-operated (two 75Ah 12VDC sealed lead acid batteries); Dynamic Rhino series controller; pneumatic tires (4.00-5 front, 3.00-10 rear); remote DC 24V 8A charger; fabric back upholstery (ignition resistant).

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• COMFORT WINDJOY SCOOTER LY-EW302 (K022369)

Submission Summary (Full Text)

{0}------------------------------------------------

K063032

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 : [phone] FAX : [phone]

#### 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 : [phone] FAX : [phone]

## C.1 SUMMARY TABLE

| ITEMS | SUBJECT DEVICE | PREDICATE<br>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<br>intended for<br>medical<br>purposes to<br>provide mobility<br>to persons<br>restricted to a<br>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<br>Rhino series |
| Batteries | | |
| Quantity | Two | Two |
| Type | Sealed lead acid, 75Ah<br>12VDC | Sealed lead acid, 40Ah<br>12VDC |
| Range per charge | 75 km / 46.8 miles | 28 miles |
| ITEMS | SUBJECT DEVICE | PREDICATE<br>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<br>( with battery ) | 165 lbs<br>( w/o battery ) |
| RECHARGER | DC 24V 8A<br>Remote | DC 24V 5A<br>Remote |
| Safe climbing angle | SAME | 12° |
| Warranty | | |
| 3 years | SAME | Main frame |
| 1 year | | Controller / gear motor<br>main components w/o<br>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 : [phone] FAX : [phone]

{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 : [phone] FAX : [phone]

#### 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 [phone] . 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 [phone] or [phone] 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

Page 1 of 1