(34 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Lightweight Power Mobility Scooter, S34 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.
The provided text does not contain information about acceptance criteria for a device's performance that would typically be described in a study, such as diagnostic accuracy metrics (sensitivity, specificity, AUC). Instead, it describes a medical device called the "HEARTWAY Lightweight Power Mobility Scooter, S34" and its substantial equivalence to a predicate device.
The "Performance Testing" section refers to compliance with established safety and engineering standards for electrically powered wheelchairs and scooters, rather than specific performance metrics for a diagnostic or AI device.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information is not present in the provided document.
The document primarily focuses on:
- Device Description: A lightweight electric mobility scooter.
- Intended Use: To provide mobility to persons restricted to a seated position.
- Substantial Equivalence: Comparison to a predicate device (HEARTWAY Lightweight Power Mobility Scooter, S33 (K071007)) based on materials, strength, fatigue, suspension, back upholstery, electronic systems (which passed UL certification), and safety levels.
- Differences noted: 4-wheels vs. 3-wheels, "free-wheel" manual feature, cruising range, overall appearance, weight capabilities, and maximum speed. These differences were deemed not to affect safety significantly.
- Performance Testing Mentioned:
- 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 compliance standards, not performance metrics related to diagnostic accuracy or AI.
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Image /page/0/Picture/0 description: The image shows the letterhead for Heartway Medical Products Co., LTD. The letterhead includes the company logo, address, phone number, website, and email address. The image also includes the text "510(k) SUMMARY" and the date "MAY 23 2010".
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 40850, Taiwan, ROC
Date summary prepared: Device Name:
April 17, 2010
Proprietary Name: Common or Usual Name: Classification Name:
. .
HEARTWAY Lightweight Power Mobility Scooter. S34 POWERED SCOOTER MOTORIZED 4-WHEELED VEHICLE, Class II, 21 CFR 890.3800
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 Mobility Scooter, S34 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 Lightweight Power Mobility Scooter, S33 (K071007)
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Image /page/1/Picture/0 description: The image shows a logo for HEARTWAY. The logo consists of a stylized floral design above the word "HEARTWAY" in block letters. The floral design is abstract and appears to be composed of several rounded shapes arranged to resemble petals or leaves. The entire logo is in black against a white background.
HEARTWAY MEDICAL PRODUCTS CO .. LTD. NO.6. ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL : 886-4-23580357 (Sales) - 23583232 (Rep) FAX : 886-4-235907B6 E-mail sales@boarbeas.com is
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 a bold, sans-serif font. The letters are black, and the background is white. The logo is simple and recognizable.
ISC-9001:
CERTIFICATED
Summary for substantial equivalence comparison:
.
According to the above table that the intended use between the two devices is the Mainframes materials of the two devices are fixed, and all meet the strength and same. fatigue tests and they use the same material aspects. The suspension of cross brace, footplates, incline degree 10°, and armrest type 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, motor, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
The cruising range per charge for the two devices is difference. This means the new device is 6~9 miles cruising range. the predicate device is 18 miles. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
The main difference for the two devices is 4-wheels for the new device and 3-wheels for the predicate device. Besides, the new device has a "free-wheel" manual feature that means the new device can be moved without turning it on. Free-wheeling is accomplished by adjusting the free-wheeling lever to the free-wheeling position. Thus the main difference for the two devices is overall appearance, weight capabilities, maximum speed, and the weight are differences between the two devices. The safety levels of the two devices are the same and the overall appearance differences are not safety aspect. They are substantially equivalent.
D2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Heartway Medical Products Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin-Chu City, 30067, Taiwan Republic of China
MAY 2 3 2010
Re: K101142
Trade/Device Name: HEARTWAY Lightweight Power Mobility Scooter, S34 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 17, 2010 Received: April 22, 2010
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. 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
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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.
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/CDRH/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;
Mark N. Melkerson
Director . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ):___ K
Device Name: HEARTWAY Lightweight Power Mobility Scooter, S34
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)
... ...
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
:
510(k) Number K101142
F1
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).