(351 days)
Not Found
No
The device description and performance testing focus on basic mobility functions and standard safety/performance standards for powered scooters, with no mention of AI/ML terms or capabilities.
No.
The device is intended to provide mobility to persons restricted to a seated position, which addresses a functional need rather than directly treating or curing a medical condition.
No
The device is a power mobility scooter, intended to provide mobility, not to diagnose a condition or disease.
No
The device description clearly outlines a physical, battery-operated scooter with wheels, a seat, armrests, and hand controls. The performance studies listed are all related to the physical and electrical characteristics of a mobility device, not software.
No, 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 describes a device used on a person to assist with physical function, not a device used to examine specimens from the body to diagnose or monitor a condition.
- Device Description: The description details a "powered scooter" with wheels, a seat, and controls. This is a physical mobility aid.
- Lack of IVD Characteristics: 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 samples
- Providing diagnostic or monitoring information based on sample analysis
The performance studies listed are all related to the physical performance, safety, and durability of a mobility device, not the analytical performance of a diagnostic test.
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. S15 is an indoor / outdoor powered scooter that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the powered 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 external battery recharger.
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)
Performance Testing:
-
- EMC Report ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).
-
- ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999.
-
- ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs, 2001.
-
- ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012.
-
- ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008.
-
- ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space, 2008.
-
- ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001.
-
- ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998.
-
- ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 1998.
-
- ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
-
- ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008.
-
- ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012.
-
- ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989.
-
- ISO 7176-14 : Power and control system for electric wheelchairs, 2008.
-
- ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996.
-
- ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
-
- ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.
Results: The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an emblem featuring a stylized image of an eagle with three human profiles nested within its form. The profiles are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
HEARTWAY Medical Products Co., Ltd. Dr. Jen, Ke-Min, Official Correspondent No.6, Road 25, Taichung Industrial Park Taichung City 40850 TAWIAN, R.O.C.
Re: K132855
Trade/Device Name: HEARTWAY Power Mobility Scooter, S15 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: July 25, 2014 Received: July 30, 2014
Dear Dr. Jen, Ke-Min:
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. Isting 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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132855
Device Name
HEARTWAY Power Mobility Scooter, S15
Indications for Use (Describe)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
e: 2014.08.29 38 -04'00'
3
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4
Image /page/4/Picture/0 description: The image shows a logo with a purple butterfly-like shape against a blue square. To the left of the square is a thin yellow line with a circle at the top. Below the square and line, the word "HEARTWA" is written in bold, black letters.
Image /page/4/Picture/2 description: The image contains two logos. The first logo is the "TUV CERT" logo, which is a blue circle with the words "TUV" in bold blue letters at the top and the word "CERT" in smaller blue letters below it. The second logo is a rounded rectangle with the words "ISO-9001 CERTIFICATED" in blue letters. The logos appear to be certification marks, indicating that a product or organization has met certain standards.
66 510(k) SUMMARY "
K132855
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 40850, Taiwan, ROC
| Date summary prepared: | August 21, 2014 |
|---|---|
| Device Name: | |
| Proprietary Name: | HEARTWAY Power Mobility Scooter, S15 |
| Common or Usual Name: | POWERED SCOOTER |
| Classification Name: | MOTORIZED 4-WHEELED VEHICLE, Class II, |
| 21 CFR 890.3800 | |
| Product Code: | INI |
| Company contact | Henry Wu (henry@heartway.com.tw) |
| Official Correspondent | Dr. Jen, Ke-Min |
| Tel: +886-4-23580357 Fax: +886-3-5209783 | |
| Email: ceirc.jen@msa.hinet.net |
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. S15 is an indoor / outdoor powered scooter that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the powered 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 external battery recharger.
Performance Testing:
-
- EMC Report ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).
-
- ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999.
5
Image /page/5/Picture/0 description: The image shows a logo with a purple butterfly-like shape against a blue square. The butterfly shape is abstract and consists of rounded petals. To the left of the butterfly, there is a thin yellow line with a small circle at the top. Below the butterfly and the line, the word "HEARTWA" is written in bold, black letters.
EARTWAY MEDICAL PRODUCTS
Image /page/5/Picture/2 description: The image contains two logos on a white background. The first logo is for "TUV CERT" and features the letters "TUV" stacked on top of the word "CERT" inside of a circular design. The second logo is a rounded rectangle that contains the text "ISO-9001 CERTIFICATED".
-
- ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs, 2001.
-
- ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012.
-
- ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008.
-
- ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space, 2008.
-
- ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001.
-
- ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998.
-
- ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 1998.
-
- ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
-
- ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008.
-
- ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012.
-
- ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989.
-
- ISO 7176-14 : Power and control system for electric wheelchairs, 2008.
-
- ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996.
-
- ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
-
- ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.
Device major components description
The maximum weight bearing capacity of the device is 160 kgs / 350 lbs.
The feature of the body structure, the rear two wheels can always contact the surface, and the vehicle can operate on the rough surface. We provide the components and assembling drawing in the User's Manual. But the following surfaces are recommended not to operate on:
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Image /page/6/Picture/0 description: The image is a company logo for Heartway Medical Products Co., LTD. The logo includes a purple butterfly-like design on the left side of the image. The company's address is listed as No. 6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. 408, and their phone number is 886-4-23580357.
- Sand surface ●
- Wet or icy surface
- Road maintenance hole metal cover
- Too steep incline over 10 degrees.
- Turning Radius 1,280 mm / 50.4"
- Ground clearance 80 mm / 3.15"
- Kerb climbing ability 75 mm / 2.9"
Legally marketed device for substantial equivalence comparison:
Predicate Device: HEARTWAY Power Mobility Scooter, S12 (K092650)
7
Image /page/7/Picture/0 description: This image shows the logo and contact information for Heartway Medical Products Co., LTD. The logo includes a stylized butterfly shape in purple and blue, along with the company name in bold letters. The contact information includes the company's address at No.6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. 408, as well as their phone number, fax number, website, and email address.
Comparison Table:
| Comparison
items | PREDICATE
DEVICE | SUBJECT
DEVICE | Safety and
effectiveness of
subject device
compared to the
predicate. |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| BRAND
NAME | HEARTWAY | | Same |
| MANUFACT
URER | HEARTWAY Medical Products Co., Ltd. | | Same |
| SERIES | Power Mobility Scooter Series | | Same |
| MODEL NO | S12 | S15 | Same |
| 510K NO | K092650 | K132855 | Same |
| INTENDED
USE | The device is intended
for medical purposes to
provide mobility to
persons restricted to a
sitting position. | | Same |
| Frame | Folded | | Same |
| Frame
material | Carbon Steel Pipe | | Same |
| Overall
dimension | | | |
| Overall
length | 1400 mm / 55.1" | | Same |
| Overall
width | 700 mm / 27.5" | | Same |
| Overall
height | 1360 mm / 53.5" | | Same |
| | | | |
| Seat Width | 620 mm / 24.5" | Same | Same |
| Seat Height | 820 mm / 32.25" | Same | Same |
| Weight
limit | 160 kgs / 352 lbs | Same | Same |
| Maximum
speed | 9.6 km/h ( 6.0 mile/h ) | Same | Same |
| Batteries
Quantity
Type
Range per
charge | Two
50 Ah 12VDC
40km / 25 miles | Same | Same |
| Motor | 24V DC, 700 W | Same | Same |
| Rear wheels | 13" x 3.5" solid x 2 | Same | Same |
| Casters | 13" x 5.0" solid x 2 | Same | Same |
| Footplates | ABS | Same | Same |
| Suspension | Cross brace | Same | Same |
| Incline | 10 degrees | Same | Same |
| Turning
Radius | 1,280 mm / 50.4" | Same | Same |
| Ground
clearance | 75 mm / 2.9" | Same | Same |
| Kerb
climbing
ability | 80 mm / 3.1" | Same | Same |
| Back
upholstery | Fabric | Same | Same |
| Armrest
types | Flip-backward | Same | Same |
| Wheel Lock | Push-to-Lock | Same | Same |
| | | | |
| Warranty | 3 years: Main frame
1 years: Controller / gear
motor / batteries w/o
exhaustive and wear
parts | Same | Same |
| Patient
contacting
materials | 1.Seat PVC material
2.Hand grip PVC material
3.Seat belt PVC material | Same | Same |
| Biocompatibility | ISO 10993-1
ISO 10993-5 | Same | Same |
| Differences: | | | |
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | Safety and
effectiveness of
subject device
compared to the
predicate. |
| Wheelchair
Weight | w/ batteries 132 kgs(2911bs)
w/o batteries: 94 kgs (207 lbs) w/o batteries 98kgs (216 lbs) | w/ batteries 136kgs(299 lbs) | 4 kgs difference is
about 3.03% of
the predicate
weight, not to
change the center
of weight much. |
| Electronics
Controller | RHINO
DS112K Drive | RHINO
DS120 Drive | Both controllers
are TUV certified. |
| Recharger
model | 24VDC
4C24080A
(UL E201162 certified) | 24VDC
4F24050
(UL E241359 certified) | Both
rechargers are UL
certified. |
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Image /page/8/Picture/0 description: The image shows a logo with a purple butterfly-like design on a blue square. Below the square, the word "HEARTWAY" is written in bold, dark blue letters. A thin yellow line extends from the left side of the image, adding a subtle design element.
HEARTWAY MEDICAL PRODUCTS CO.,LTD.
TÜV-GERTA
CERTIFICATED
P
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw al
6
Image /page/8/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email is preceded by the text "E-mail :".
9
Image /page/9/Picture/0 description: The image shows a logo with a purple flower-like shape on a blue square. A yellow line connects the flower to the word "HEARTWA" in bold black letters. The logo appears to be for an organization or company with a focus on heart or well-being.
HEARTWAY MEDICAL PRODUCTS CO .. L
NO.6, ROAD 25, TAICHUNG INDUSTRIAL TEL: 886-4-23580357 (Sales) . 23583232 (Rep) FAX: 886-4-23590786 Web : www.heartway.com.tw
Image /page/9/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email is preceded by the text "E-mail :". The text is in a sans-serif font and is black. The background is white.
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes of two devices are folded. All materials of the two devices meet the strength and fatigue tests and they use the same material. The same size of wheels, the weight limit, cruising range, maximum speed, incline capabilities, suspension of cross brace, footplates, armrest type, the
10
Image /page/10/Picture/0 description: The image shows the logo and contact information for HEARTWAY MEDICAL PRODUCTS CO., LTD. The logo includes a stylized butterfly design in purple and blue. The text provides the company's address, phone and fax numbers (886-4-23580357, 886-4-23590786), website (www.heartway.com.tw), and email address (sales@heartway.com.tw).
warranty of the components, and the relevant specifications for ground clearance and curb climbing ability are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test in accordance with ISO 7176-16.
The main differences among the two devices are the different models of the electronics controller and battery rechargers. But they are all certified ones. Thus, these differences only lead to the different wheelchair weights. The differences of weight between two devices are so small, only 3.03% of the predicate wheelchair weight. The 3.03% of the different weight does not lead to the large change of the centers of weight. The centers of weight are almost at the same point, thus the safety and effectiveness aspects are the same.
Two devices also completed the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC 2, Section 21 for the EMC test. The two devices are substantially equivalent.
Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.