(17 days)
Not Found
No
The description focuses on basic mechanical and electrical components and manual user control, with no mention of AI or ML terms or functionalities.
No.
The device is a mobility aid for daily living, not intended for therapeutic treatments or to cure, mitigate, or prevent disease.
No
The provided information states that the device is "intended for medical purposes to provide mobility to persons restricted to a seated position" and describes it as a "Power Mobility Scooter". There is no mention of it being used to diagnose conditions or process any kind of diagnostic data.
No
The device description clearly outlines a physical, battery-operated electric 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 clearly stated as providing mobility to persons restricted to a seated position. This is a physical assistance device, not a diagnostic tool.
- Device Description: The description details a power mobility scooter, which is a mechanical device for transportation. It does not involve the analysis of biological samples or any in vitro procedures.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic tests, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This power mobility scooter 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)
INI
Device Description
The HEARTWAY Power Mobility Scooter, PF6 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.
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
K072/04
Image /page/0/Picture/1 description: The image shows a logo for HEARTWAY. The logo features a stylized butterfly or flower-like design above the word "HEARTWAY" in bold, sans-serif font. The butterfly/flower design is black, while the text is a darker shade of gray.
EARTWAY MEDICAL PRODUCTS CO.
S BOAD 25 TAICHUNG INDUSTRIAL PARK TAICHUNG TAIWAN B.C.
ISO-9001
CERTIFICATED
July 28, 2007
AUG 17 2007
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:
Proprietary Name: HEARTWAY Power Mobility Scooter, PF6 Common or Usual Name: POWERED SCOOTER MOTORIZED 3-WHEELED VEHICLE, Class II, Classification Name: 21 CFR 890.3800 INI Product Code:
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 Mobility Scooter, PF6 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)
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized floral design above the word "HEARTWAY" in bold, block letters. The floral design consists of four petal-like shapes arranged in a circular pattern, resembling a stylized flower or butterfly. The logo is simple and modern, with a focus on the floral element and the bold text.
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: 886-4-23590786
Image /page/1/Picture/2 description: The image shows the text "ISO-220". The text is in a simple, sans-serif font and appears to be part of a larger document or label. The text is black and the background is white.
TÜV
Summary for substantial equivalence comparison:
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. The cruising range per charge for the two devices is same. Moreover, the suspension of cross brace, footplates, incline degree 10°, armrest type, and 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 clectronic controller, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
Owing to the predicate device "Lightweight" power mobility scooter is more agile and easy to fold for storage or transportation and the new device is more general use. 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.
2
Public Health Service
OF HEALTH & HUMAN SERVICES · USA
DEPARTMENT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartway Medical Products Co., Ltd % Dr. Jen. Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City, 30067 Taiwan, ROC
Re: K072104
Trade/Device Name: Heartway Power Mobility Scooter, PF6 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: July 28, 2007 Received: July 31, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
AUG 1 7 2007
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) This letter will allow you to begin harketing your arvice as easence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your d premarket notification. The FDA inding of substantial equive 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
r in the may and 100 and 100 and 100 at any and one note the required If you desire specific advice for your device of College note the regulation entitled.
contact the Office of Compliance at (240) 276-0120 - 169 OFF P - 807 07). You may obta contact the Office of Complance at (240) 276 - 8 x (21.97). You may obtain
"Misbranding by reference to premarket notification" (21 x from the Division of Small "Misbranding by reference to prematicanon" (182 Act from the Division of Small
other general information on your responsibilities under (800) 638,2041 ( other general information on your responsibilities and toil-free number (800) 638-2041 or Manufacturers, International and Collsumer Rissistance at only with and with the stry/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 Power Mobility Scooter, PF6
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)
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 2072104