P&F POWER WHEELCHAIR, HC-510

K070350 · P & F Brother Ind., Corp. · ITI · Mar 14, 2007 · Physical Medicine

Device Facts

• Record ID: K070350
• Device Name: P&F POWER WHEELCHAIR, HC-510
• Applicant: P & F Brother Ind., Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• 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

The P & F Powered Wheelchair, HC-510 is a battery-operated indoor/outdoor electric scooter. It features a four-wheeled base, seat, armrests, and a front basket. The rider operates the device using hand controls located on the steering column. The scooter is designed to be disassembled for transport and includes an onboard battery charger. It provides mobility for individuals restricted to a seated position. The device utilizes electronic controllers, motors, and batteries to facilitate movement.

Clinical Evidence

Bench testing only. Performance testing included EMC compliance with ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995.

Technological Characteristics

Battery-operated electric scooter; four-wheeled base; hand-controlled steering column; electronic controller, motor, and battery system; UL-certified electronic components; disassemblable frame.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• FORYOU POWERED WHEELCHAIR, FC-100 (K061693)

Submission Summary (Full Text)

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

MAR 1 4 2007

February 1, 2007

Image /page/0/Picture/1 description: The image shows the logo for P & F BROTHER IND., CORP. The logo consists of a hexagon shape with three triangles inside. To the right of the logo is the text "P & F BROTHER IND., CORP."

NO. 12, 611 ROAD, INDUSTRIAI. PARK. TAICHUNG, TAIWAN. R.O.C. TEL : [phone] FAX : [phone]

## 510(k) SUMMARY " દર્

Submitter's Name: P & F BROTHER IND., CORP.

No.12, 6TH Road, Industrial Park, Taichung, 40755, Taiwan, ROC

Date summary prepared:

Device Name:

P & F POWERED WHEELCHAIR, HC-510 Proprietary Name: Common or Usual Name: POWERED WHEELCHAIR Classification Name: POWERED WHEELCHAIR, Class II, 21 CFR 890.3860

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 P & F POWERED WHEELCHAIR, HC-510 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. 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: FORYOU POWERED WHEELCHAIR, FC-100 (K061693)

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo and text. The logo is a hexagon containing three triangles. To the right of the logo, the text reads "P & F BROTHER IND., CORP."

NO. 12, 6" ROAD, INDUSTRIAL PARK. TAICHUNG, TAIWAN, R.O.C. TEL : [phone] = FAX : [phone]

## Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are fixed. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and the incline degree are all the same. Back upholstery material is also the same fabric. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, motor and the competent switches and switching power supplies. Though the two devices use the different recharge and also passed the UL certificated. Thus the same safety level for the two devices is assured.

The major differences existing are the overall dimensions, and the subject device is heavier than the predicate device. The overall appearance differences are not safety Thus the new device is substantially equivalent to the predicate devices in this aspect. aspect.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

P & F Brother Ind., Corp. % Roc Chinese-Europe Industrial Research Society Jen Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan)

MAR 1 4 2007

Re: K070350

Trade/Device Name: P & F Powered Wheelchair, HC-510 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 1, 2007 Received: February 6, 2007

Dear Jen 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.

{3}------------------------------------------------

Page 2 - 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 yours,

Mark N. Melkerson

Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510 (K) Number ( If Known ):_ K

Device Name: P & F POWER WHEELCHAIR, HC-510

Indications for Use:

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

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

Prescription Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 10703 Page 1 of 1