(41 days)
Not Found
No
The description focuses on basic powered wheelchair functionality controlled by the user and does not mention any AI/ML features.
No
The device is a powered wheelchair intended for mobility, not to treat or cure a medical condition. It provides support and assistance for daily living to individuals with disabilities.
No
Explanation: The device description states its purpose is to provide mobility. There is no mention of it being used to diagnose any medical condition or disease.
No
The device description clearly states it is a physical, battery-operated wheelchair with a 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 one.
- Device Description: The description details a powered wheelchair, which is a mobility aid. There is no mention of analyzing biological samples or providing diagnostic information.
- 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
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The performance studies mentioned (EMC Report, ANSI / RESNA standards) are related to the electrical and mechanical safety and performance of a mobility device, not diagnostic accuracy.
Therefore, this device 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
ITI
Device Description
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.
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, scooters, and their chargers - requirements and test methods)
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
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
0
OCT 2 8 2008
September 10, 2008
Image /page/0/Picture/2 description: The image shows a logo that appears to be for a car brand. The logo is in the shape of a hexagon, and inside the hexagon are three diagonal shapes that are similar to triangles. The logo is black and white and has a grainy texture.
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)
1
Image /page/1/Picture/0 description: The image is a black and white graphic that appears to be a stylized representation of a crown or headdress. The design is composed of many small dots and dashes, creating a textured effect. The crown has a wide base and rises to several peaks, giving it a regal appearance. The overall impression is one of delicate artistry, despite the simplicity of the individual elements.
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.
2
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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
3
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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), plcase contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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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