P & F POWER WHEELCHAIR, MODEL HC-500SB

K082722 · P & F Brother Ind., Corp. · ITI · Oct 28, 2008 · Physical Medicine

Device Facts

• Record ID: K082722
• Device Name: P & F POWER WHEELCHAIR, MODEL HC-500SB
• Applicant: P & F Brother Ind., Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 28, 2008
• 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

Battery-operated indoor/outdoor powered wheelchair; four-wheeled base with seat. Rider operates device via hand controls on steering column. Disassemblable for transport; includes onboard battery charger. Electronic systems (controller, batteries, motor, switches) are UL-certified. Used by patients with mobility restrictions; operated by the user. Provides independent mobility.

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 electromagnetic compatibility and safety. Upholstery materials passed resistance ignition testing per SGS.

Technological Characteristics

Battery-operated powered wheelchair; four-wheeled base. Electronic system includes controller, motor, and switches. Materials meet strength and fatigue testing requirements. Upholstery fabric tested for ignition resistance. Complies with ANSI/RESNA WC/Vol.2-1998 and IEC/EN standards for electrical safety and EMC.

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

• P & F POWER WHEELCHAIR, HC-510 (K070350)

Submission Summary (Full Text)

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K082722

OCT 2 8 2008

September 10, 2008

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## P & F BROTHER IND., CORP.

´ ROAD. INDESTRIAL PARK, TAICHUNG, FAIWAN. R.O.C. NO. 12.6 11:1 886-4-2359-1000 - 1 AX : 886-4-2359-0921

### 510(k) SUMMARY "

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

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

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

P & F POWERED WHEELCHAIR, HC-500SB POWERED WHEELCHAIR 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-500SB is an indoor / outdoor wheelchair 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, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: P & F POWER WHEELCHAIR, HC-510 (K070350)

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# P & F BROTHER IND., CORP.

ROAD, INDI STREAF PARK. TAICHUNG. FAIWAN. R.O.C. [ EL = 886-4-2359-1000 = FAX = 886-4-2359-0921

### Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are fixed. 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 maximum speeds, suspension of cross brace, footplates, armrest, and the wheel lock are all the same. The seat and back upholstery materials are also the same fabric and passed the resistance ignition test by SGS.

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.

Owing to the subject device is lighter and ingenious than the predicate device, the major differences existing are the overall dimensions, weight capabilities, incline degree, and cruising range. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

P&F Brother Ind. Corporation % ROC Chinese-European Industry Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan) 30067

OCT 2 8 2008

Rc: K082722

> Trade/Device Name: P & F Power Wheelchair, HC-500SB Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair. Regulatory Class: Class II Product Codc: ITI Dated: September 10, 2008 Received: September 17, 2008

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

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Page 2 - Dr. Ke-Min Jen

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,

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), plcase contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Mulkeran

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

Enclosure

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## Indications for Use

510 (K) Number ( If Known ):

Device Name: P & F POWER WHEELCHAIR, HC-500SB

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 Use \$\sqrt{ }\$

彩

8

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

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