(42 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Attendant-Controlled Power Chair, TC1 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.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. Based on the document, it is a 510(k) summary for a powered wheelchair (HEARTWAY Attendant-Controlled Power Chair, TC1) that aims to establish substantial equivalence to a predicate device.
The document mentions:
- 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)". These are standards that the device was tested against.
- Substantial Equivalence Comparison: The new device (TC1) is compared to the HEARTWAY Power Tilt Seating System Power Chair, P16RT (K070489). The comparison focuses on intended use, materials, strength and fatigue tests, incline degree, suspension, footplates, armrest type, warranty, upholstery material (passed resistance ignition test), and electronic systems (UL certified).
However, the document does not provide:
- A table of specific acceptance criteria values and the device's reported performance against those criteria.
- Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set or ground truth establishment.
- Information about MRMC studies, standalone algorithm performance, or training set details.
Therefore, I cannot fulfill your request for a table of acceptance criteria and a detailed study description based on the provided text.
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Image /page/0/Picture/0 description: The image shows a logo with a stylized butterfly or floral design above the word "HEARTWAY" in bold, sans-serif font. The butterfly/floral design is contained within a square. The logo appears to be a company or brand identifier, possibly related to nature, health, or a similar field.
EARTWAY MEDICAL PRODUCTS CO.
(Ben) FAX:886-4-23590786
K07/006
510(k) SUMMARY "
MAY 2 1 2007
April 3, 2007
Submitter's Name: HEARTWAY Medical Products Co., Ltd. No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
HEARTWAY Attendant-Controlled Power Chair, TC1 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 Attendant-Controlled Power Chair, TC1 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)
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Image /page/1/Picture/0 description: The image shows a logo for HEARTWAY. The logo features a stylized butterfly or flower-like design above the word "HEARTWAY" in bold, block letters. The design and text are in black against a white background, creating a high-contrast image.
HEARTWAY MEDICAL PRODUCTS CO ... LTD. NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN B.O.C. TEL ; 886-4-23580357 (Sales) · 23583232 (Rep) FAX : B86-4-23590786
Image /page/1/Picture/2 description: The image shows the logo for "TUV", a German organization that provides inspection and product certification services. The logo is in black and white and features the letters "TUV" in a bold, sans-serif font. The logo is simple and recognizable, and it is often used on products that have been certified by TUV.
ISO-9001
CERTIFIED
Summary for substantial equivalence comparison:
Web www.heartway.com.tw E-mall : sales@heartway.com.tv
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 incline degree 12°, 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 main different for the two devices are the feature of the predicate device is designed for power tilt seating system, and the new device is designed for attendant-controlled to drive. Besides, the weight capabilities and the cruising range per charge for the two devices are difference. This means the new device is 300 pounds and 18 miles cruising range, and the predicate device is 500 pounds and 22.4 miles. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, temperature, and we provide the relevant specifications for ground clearance and curb climbing ability in the Owner's Manual. Thus for the real life use, the two devices are substantially equivalent.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.
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 1 2007
Re: K071006
Trade/Device Name: Heartway Attendant-Controlled Power Chair, TC1 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.
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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,
for Pedro
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: HEARTWAY Attendant-Controlled Power Chair, TCL *
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 _ V
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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| 510(k) Number | K011006 |
§ 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).