(10 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard mobility scooter, with no mention of AI or ML features.
No.
The device's stated intended use is to "provide mobility to persons restricted to a seated position," which is a supportive function, not a therapeutic one that treats or cures a medical condition.
No
The device is described as an electric scooter intended for mobility, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, battery-operated electric scooter with hardware components like wheels, a seat, armrests, and hand controls. It is not solely software.
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 mobility scooter, which is a device for physical transportation. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device is a mobility aid, falling under a different category of medical devices.
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
INI
Device Description
The HEARTWAY Lightweight Power Mobility Scooter, S33 is an indoor / outdoor electric scooter that is battery operated. It has a base with three-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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 with the word "HEARTWAY" in bold, sans-serif font at the bottom. Above the text is a black square containing a stylized, abstract floral or butterfly-like design. The design consists of rounded shapes that intersect in the center, creating a symmetrical pattern.
HEARTWAY MEDICAL PRODUCTS CO.,LTD.
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408
mail : sales@heartway.com.tw
Image /page/0/Picture/3 description: The image shows a logo for "TUV". The logo is black and white and features the letters "TUV" in a stylized font. Above the letters are two circles. Below the letters is some text that is too small to read. The logo is surrounded by a dotted oval shape.
April 4, 2007
PR 1 9
510(k) SUMMARY " 66
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 Lightweight Power Mobility Scooter, S33 POWERED SCOOTER MOTORIZED 3-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, S33 is an indoor / outdoor electric scooter that is battery operated. It has a base with three-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: WU'S 3-WHEELED NEO SCOOTER, WT-T3D (K032488)
DI
1
Image /page/1/Picture/0 description: The image shows a logo with the word "HEARTWA" in bold, sans-serif font at the bottom. Above the text is a stylized graphic resembling a four-petal flower or butterfly wings, set against a square background. The logo is black and white, with the graphic and text appearing in black against a white background.
HEARTWAY MEDICAL PRODUCTS CO.
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK. TAICHUNG TAIWAN I :886-4-23580357 (Sales) - 23583232 (Rep) FAX :886-4-2359078
Image /page/1/Picture/3 description: The image contains two logos. The top logo is the TUV logo, which is a circle with the letters "tuv" inside. The bottom logo is a rectangle with the text "ISO-9001 CERTIFICATED" inside. The logos are both black and white.
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 weight capabilities, maximum speed, suspension of cross brace, footplates, 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, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
The main difference for the two devices is overall appearance. Besides, the incline degree is 8° for the predicate device and the new device can drive under 10° slope. We provide the relevant specifications for ground clearance and curb climbing ability in the Owner's Manual. Thus, the user is not allowed to operate the device on the incline angle higher than the specified angle. The safety levels of the two devices are the same when operating the devices on the different inclines. They are substantially equivalent.
The cruising range per charge for the two devices is difference. This means the new device is 18 miles cruising range, the predicate device is 10 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartway Medical Products Co., Ltd. % Chinese-European Industrian Research Society Dr. Ke-Min Jen No. 58, Fu-Chium Street Hsin-Chu City, Taiwan 408 Republic of China
APR 1 9 2007
Re: K071007
Trade/Device Name: Heartway Lightweight Power Mobility Scooter, S33 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: April 4, 2007 Received: April 9, 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.
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,
for Rob
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 ): K
Device Name: HEARTWAY Lightweight Power Mobility Scooter, S33
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 NEEDE
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign- IT) Division of Get eral. Restorative, and Neurological Devices
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