(67 days)
Not Found
No
The device description and performance studies focus on basic electrical and mechanical functionality, with no mention of AI or ML terms or capabilities.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is a power scooter intended to provide mobility, which is assistive but not therapeutic in nature.
No
The device description and intended use clearly state that it is a power mobility scooter designed to provide mobility, not to diagnose medical conditions.
No
The device description clearly outlines a physical, battery-operated scooter with wheels, a seat, armrests, 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 "to provide mobility to persons restricted to a seated position." This is a functional purpose related to physical movement and support, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a power mobility scooter, which is a mechanical device for transportation. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes
Therefore, the HEARTWAY Power Mobility Scooter, S8 is a medical device, but it falls under a different category than In Vitro Diagnostics.
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)
INI
Device Description
The HEARTWAY Power Mobility Scooter, S8 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)
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 Power Mobility Scooter, PT7 (K073044)
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
§ 890.3800 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).
0
Image /page/0/Picture/0 description: The image shows a logo on the left and some text on the right. The logo is a stylized floral design with several petals. The text on the right includes the word "HEART" in large, bold letters, followed by an address "NO.6, ROAD", a telephone number "TEL:886-4-2", a website "Web: www.he", and an email address "E-mail: sales".
HEARTWAY MEDICAL PRODUCTS CO
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 40
TEL:886-4-23580357 (Sales)-23583232 (Rep) FAX:886-4-23590786
Web: www.heartway.com.tw
Image /page/0/Picture/4 description: The image is blurry and contains some text. The text is not clear enough to be read. The image is mostly white with some black text in the upper portion of the image.
ISO-9001
CERTIFICATED
K6921SS
દ દ 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:
July 5, 2009
Proprietary Name: Common or Usual Name: Classification Name:
HEARTWAY Power Mobility Scooter, S8 POWERED SCOOTER MOTORIZED 4-WHEELED VEHICLE, Class II, 21 CFR 890.3800 INI
Indications for Use:
Product Code:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The HEARTWAY Power Mobility Scooter, S8 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 Mobility Scooter, PT7 (K073044)
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized floral design above the word "HEARTWAX". The floral design is composed of several rounded shapes arranged in a circular pattern, resembling petals or leaves. The word "HEARTWAX" is written in a bold, sans-serif font, with each letter clearly defined. The logo has a simple, yet distinctive appearance.
HEARTWAY MEDICAL PRODUCTS CO .. LTD.
10.6. ROAD 25. TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 -4-23580357 (Sales)- 23583232 (Ren) FAX · 886-4-23590788
Image /page/1/Picture/3 description: The image shows a logo with the letters "TUV" in a stylized font at the top. Below the logo, there is a box with the text "ISO-9001 CERTIFIED" inside. The text is in a smaller font size and is less clear than the logo.
Summary for substantial equivalence comparison;
According to the above table that the intended use between the two devices is the same. Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects. Moreover, the maximum speed, the suspension of cross brace, footplates, armrest type, and even the overall dimensions for the two devices are similar. 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, recharger, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
Owing to the predicate device is three wheels scooter and the new device is four wheels scooter. Thus the main differences for the two devices are including weight capabilities, maximum slope, weights, cruising range, and the warranty. The safety levels of the two devices are the same and the differences of the overall weight and outer appearance are not safety aspect. They are substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
SEP 2 1 2009 Heartway Medical Products Co., LTD % Chinese-European Industrial Research Society Dr. Ke-Min Jen No., 58, Fu-Chiun Street
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Re: K092155
Hsin-Chu City China (Taiwan) 408
Trade/Device Name: HEARTWAY Power Mobility Scooter, S8 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 5, 2009 Received: July 16, 2009
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 iddictions 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, Or ug, 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 misbaranding and adulteration.
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 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
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark McMillan
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 Mobility Scooter, S8
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
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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