(46 days)
Not Found
No
The description focuses on basic power chair functionality controlled by the user via hand controls and does not mention any AI/ML features.
No.
The device is a power chair intended for mobility, not to treat or cure any medical condition.
No
Explanation: The device is described as a "power chair" intended to provide mobility, not to diagnose medical conditions.
No
The device description clearly outlines a physical power chair with hardware components (base, wheels, seat, armrests, battery, charger, hand controls). It is not solely software.
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 test performed on samples from the human body.
- Device Description: The description details a power chair, which is a mobility aid. There is no mention of analyzing biological samples or performing any kind of diagnostic test.
- Lack of IVD Indicators: 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 specific substances (analytes).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The performance testing mentioned (EMC Report and standards related to electrically powered wheelchairs) further supports that this is a mobility device, not an IVD.
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 (comma separated list FDA assigned to the subject device)
ITI
Device Description
The HEARTWAY Power Chair. P23 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HEARTWAY Attendant-Controlled Power Chair, TCI (K071006)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a stylized floral design above the text "HEARTWAY". The floral design is composed of several rounded shapes arranged in a circular pattern, resembling petals or leaves. The text "HEARTWAY" is written in a bold, sans-serif font.
EARTWAY MEDICAL PRODUCTS CO.
MAR 2 2 2010
NO.6, ROAD 25. TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408
TEL:886-4-23580357 (Sales)-23583232 (Rep) FAX:886-4-23590786
Web: www.heartway.com.tw
E-mail: sales@heartway.com.tw
Image /page/0/Picture/3 description: The image shows a logo for TÜV, a German organization that provides inspection and product certification services. The logo consists of the letters "TÜV" in a bold, sans-serif font, with a stylized crown-like symbol above the letters. The logo is surrounded by some blurry artifacts, possibly due to the image quality or compression.
January 27, 2010
510(k) SUMMARY "
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 40850, Taiwan, ROC
Date summary prepared:
Device Name:
Proprietary Name: HEARTWAY Power Chair, P23 POWERED WHEELCHAIR Common or Usual Name: 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 HEARTWAY Power Chair. P23 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair 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: HEARTWAY Attendant-Controlled Power Chair, TCI (K071006)
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized butterfly or flower design above the word "HEARTWA". The butterfly/flower is composed of several rounded shapes arranged in a circular pattern, all filled in with solid black. The word "HEARTWA" is in a bold, sans-serif font, also in black, and appears to be the beginning of a longer word or phrase.
HEARTWAY MEDICAL PRODUCTS CO. BOAD 25 TAKCHUNG INDUSTRIAL PARK TANCHUNG TAMAA (Sales) 23583232 (Rep) FAX : 886
Image /page/1/Picture/2 description: The image contains two logos. The first logo is a TUV logo, which is a certification mark. The second logo is an ISO-9001 certified logo, which is a quality management system standard. The ISO logo is contained within a rounded rectangle.
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes of two devices are folded, materials of the two devices all meet the strength and fatigue tests and they use the same material aspects. The same weight limit, cruising range, suspension of cross brace, size of rear wheels, footplates, armrest type, and the warranty are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
The main different for the two devices are the feature of the predicate device is designed for attendant-controlled to drive, and the new device is designed for general used to drive. Thus, the differences between the two devices are very minor including overall dimension, wheelchair weight, size of front wheels and seat, incline capabilities, and the relevant spècifications for ground clearance and curb climbing ability in the User's Manual. Thus for the real life use, the two devices are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Heartway Medical Products Co., Ltd. % Dr. Ke-Min Jin ROC Chinese - European Ind. No. 58, Fu-Chuin Street Hsin Chu City, TW HSQ China (Taiwan) 30067
MAR 2 2 2010
Re: K100327
Trade/Device Name: HEARTWAY Power Chair, P23 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 27, 2010 Received: February 4, 2010
Dear Dr. Jin:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Dr. Ke-Min Jin
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ): K
Device Name: HEARTWAY Power Chair, P23
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 NEEDE
Concurrence of CDRH, Office of Device Evaluation (ODE)
MHILLIAM H. HODGES FOR M.MEELKERSON
(BY) John al. 68
Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K100327