(43 days)
Not Found
No
The description focuses on mechanical and electrical components and control via hand controls, with no mention of AI or ML.
No.
Explanation: The device is intended to provide mobility, which is assistive rather than therapeutic. While it may help manage the effects of a condition, it does not directly treat or cure it.
No
Explanation: The device is a power chair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, hardware-based electric scooter with wheels, a seat, armrests, and hand controls, indicating it is not a software-only medical 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 power chair/scooter, which is a mobility aid. It does not mention any components or functions related to testing biological samples or diagnosing conditions.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
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 Lightweight Power Chair, P15 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.
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.
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
K07/005
March 30, 2007
Image /page/0/Picture/1 description: The image shows a logo with a stylized butterfly or flower design above the word "HEARTWAY" in bold, sans-serif font. The butterfly/flower is black against a white background, and it is positioned above the text. The overall design is simple and modern.
HEARTWAY MEDICAL PRODUCTS CO.
Image /page/0/Picture/3 description: The image shows a logo with the letters "TUV" in a bold, sans-serif font. The letters are stacked vertically, with the "T" on top and the "UV" below it. There are some other letters and symbols around the logo, but they are not clear. The logo is black and white.
ISO-9001
CERTIFIED
510(k) SUMMARY "
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC
Date summary prepared:
Device Name:
HEARTWAY Lightweight Power Chair, P15
Proprietary Name: Common or Usual Name: Classification Name:
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 HEARTWAY Lightweight Power Chair, P15 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:
HEARTWAY Power Tilt Seating System Power Chair, P16RT (K070489)
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized floral design above the word "HEARTWAY". The floral design is composed of several rounded shapes arranged to resemble a flower or a butterfly. The word "HEARTWAY" is written in a bold, sans-serif font, with each letter clearly defined. The logo appears to be for a company or organization named Heartway.
HEARTWAY MEDICAL PRODUCTS CO ... TD. 0.6 ROAD 25 TAICHUNG INDUSTRIAL PARK TAICH ING TAIWAN B O.C. :886-4-23580357 (Sales) 23583232 (Rep) FAX:886-4-23590786
Image /page/1/Picture/2 description: The image shows a logo for "TUV", which is a German organization that provides inspection and product certification services. The logo is in black and white and features the letters "TUV" in a stylized font. The letters are stacked on top of each other, with the "T" on top, the "U" in the middle, and the "V" on the bottom. The logo is surrounded by a faint dotted pattern.
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 maximum speed 9.6 km/hr, suspension of cross brace, 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 major differences existing are the overall dimensions, cruising range, and the incline degrees are differences between the two devices. Besides, the special designed for the predicate device with power tilt seating system and the new device is designed for more lightweight. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartway Medical Products Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan ROC Republic of China
MAY 2 2 2007
Re: K071005
Trade/Device Name: Heartway Lightweight Power Chair, P15 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 24, 2007 Received: June 23, 2007
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 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 -- Dr. Ke-Min Jen
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 (240) 276-0120 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
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: HEARTWAY Lightweight Power Chair, P15
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)
(Division Sign-Off)
Concurrence of CDRH, Office of General, Restorative,
Division of Device Evaluation (ODE)
and Neurological Devices
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