(161 days)
Not Found
No
The description focuses on basic mechanical and electrical components and standard performance testing for mobility devices. There is no mention of AI, ML, or any features that would suggest intelligent decision-making or learning capabilities.
Yes
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position, fulfilling a therapeutic role by assisting individuals with mobility limitations.
No
The device is a power scooter intended to provide mobility to individuals restricted to a sitting position, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical power scooter with hardware components like wheels, a seat, a tiller column, and a battery. The performance studies also focus on physical characteristics and safety standards for a mobility device, not software performance.
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 sitting position." This clearly describes a device used for physical assistance and mobility, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a power scooter with wheels, a seat, controls, etc. This is consistent with a mobility aid, not a device for analyzing biological samples.
- Performance Studies: The performance studies listed are related to the physical and electrical safety and performance of a wheelchair/scooter (stability, braking, speed, dimensions, EMC, biocompatibility of contacting materials), not the analytical or clinical performance of an in vitro diagnostic test.
IVD devices are used to test samples like blood, urine, tissue, etc., outside of the body to gain information about a person's health. This device is used directly on the person for mobility.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes
INI
Device Description
BRIO S19 power scooter is battery powered and configured with four solid wheels, a seat, a turning tiller column, a upper panel control, a main frame, a cross bar and an anti-tipper.
BRIO S19 power scooter is operated by two rear wheels as the drive wheels and two front wheel as the steering wheel, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control. The main frame is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. BRIO S19 power scooter maximum weight capacity is 220 lbs (100 kg), and BRIO S19 power scooter maximum speed is 5 mile/hr (8 km/hr).
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:
- (1) EMC Test: ANSI / RESNA WC-2:2009 (Section 21) Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods
- CISPR 11:2009
- IEC61000-4-2: 2008
- IEC61000-4-3: 2006+A1:2008+A2:2010
- IEC61000-4-4:2004
- IEC61000-4-5:2005
- IEC61000-4-6:2008
- IEC61000-4-8:2009
- IEC61000-4-11:2004
- ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. (2)
- ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric (3) wheelchairs, 2001.
- (4) ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes, 2012.
- ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs (ರ) for determination of theoretical distance range, 2008.
- ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass (6) and manoeuvring space, 2008.
- (7) 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 -(8) Definitions and measuring method, 1998.
- (9) ISO 7176-8 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs. 1998.
- (10) ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs, 2009.
- ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability (11) of electrically powered wheelchairs, 2008.
- (12) ISO 7176-11 Wheelchairs - Wheelchairs - Part 11: Test dummies, 2012.
- (13) ISO 7176-13 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. 1989.
- (14) ISO 7176-14 : Power and control system for electric wheelchairs, 2008.
- ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, (15) documentation and labelling, 1996.
- (16) ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
- (17) ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.
Biocompatibility information
Patient contacting materials: Seat PVC material, Hand grip PVC material, Seat belt PVC material.
We tested these patient contacting materials for compliance to the standards ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. We provide the FDA Form 3654 for these standards.
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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is composed of three distinct shapes, each resembling a human head in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2015
Heartway Medical Products Co., Ltd. Jen, Ke-Min Official Correspondent No.6 Road 25, Taichung Industrial Park, Taichung City, 40850 Taiwan
Re: K150987
Trade/Device Name: Heartway Power Mobility Scooter, BRIO S19 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 5. 2015 Received: August 19, 2015
Dear 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, 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
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Carlos L. Pena -SED/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150987
Device Name
Heartway Power Mobility Scooter, BRIO S19
Indications for Use (Describe)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a logo with a purple butterfly-like design set against a blue square. Below the square, the word "HEARTWAY" is written in bold, black letters. A thin, yellow line extends vertically from the left side of the image, ending in a small yellow circle.
Image /page/3/Picture/1 description: The image shows the contact information for Heartway Medical Products Co., LTD. The address is No. 6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. 408. The telephone number is 886-4-23580357, and the fax number is 886-4-23590786. The website is www.heartway.com.tw, and the email address is sales@heartway.com.tw.
510(k) SUMMARY 5.
| Submitter's Name: | HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park,
Taichung, 40850, Taiwan, ROC |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date summary prepared: | August 9, 2015 |
| Device Name: | |
| Proprietary Name: | HEARTWAY Power Mobility Scooter, BRIO S19 |
| Common or Usual Name: | POWERED SCOOTER |
| Classification Name | Motorized Three-Wheeled Vehicle, Class II,
21 CFR 890.3800 |
| Product Code: | INI |
| Company contact person: | Mr. Tien-hsing Yang (Email: yhead0722@hotmail.com) |
| Official Correspondent: | Dr. KE-MIN JEN (email: ceirs.jen@msa.hinet.net)
TEL: 886-3-5208829, FAX: 886-3-5209783 |
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Description of the device:
- BRIO S19 power scooter is battery powered and configured with four solid wheels, a seat, a turning tiller column, a upper panel control, a main frame, a cross bar and an anti-tipper.
4
Image /page/4/Picture/0 description: The image shows a logo with a purple flower-like design against a blue square. The flower has four petals and is positioned in the upper part of the square. A yellow line extends from the left side of the image, ending in a small circle. Below the square and line, the word "HEARTWAY" is written in bold, black letters.
EARTWAY MEDICAL PRODUCTS O
Image /page/4/Picture/2 description: The image contains two logos on a white background. The first logo is the "TUV CERT" logo, which features the letters "TUV" in a bold, sans-serif font above the word "CERT" in a smaller, sans-serif font, all enclosed within a circular border. Below this logo is a rectangular badge with rounded corners that reads "ISO-9001 CERTIFICATED" in a simple, sans-serif font. The text is arranged in two lines, with "ISO-9001" on the top line and "CERTIFICATED" on the bottom line.
- BRIO S19 power scooter is operated by two rear wheels as the drive wheels and two front wheel as the steering wheel, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control. The main frame is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. BRIO S19 power scooter maximum weight capacity is 220 lbs (100 kg), and BRIO S19 power scooter maximum speed is 5 mile/hr (8 km/hr).
- The following surfaces are recommended not to operate on: ●
- Sand surface
- Wet or icy surface
- Road maintenance hole metal cover
- � Avoid going up multiple steps.
- Avoid using escalators. Use the elevator.
- Too steep incline over 6 degrees.
- Ground clearance to battery 60 mm / 2.3"
- Curb climbing ability 45 mm / 1.7"
Performance Testing:
- (1) EMC Test: ANSI / RESNA WC-2:2009 (Section 21) Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods
- CISPR 11:2009
- IEC61000-4-2: 2008 ●
- IEC61000-4-3: 2006+A1:2008+A2:2010
- IEC61000-4-4:2004
- IEC61000-4-5:2005
- IEC61000-4-6:2008
- IEC61000-4-8:2009
- IEC61000-4-11:2004
5
Image /page/5/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters. Above the word is a stylized butterfly shape in purple and white, set against a blue square. A thin yellow line extends from the left side of the butterfly shape down to the top of the word "HEARTWAY."
HEARTWAY MEDICAL PRODUCTS CO. NO 6 BOAD 25 TAICHUNG INDUSTRIAL I 886-4-23580357 (Sales) - 23583232 (Rep)
eb:www.heartway.com.tw
E-mail:sales@heartway.com.tw
- ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. (2)
- ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric (3) wheelchairs, 2001.
- (4) ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes, 2012.
- ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs (ર) for determination of theoretical distance range, 2008.
- ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass (6) and manoeuvring space, 2008.
- (7) 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 -(8) Definitions and measuring method, 1998.
- (9) ISO 7176-8 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs. 1998.
- (10) ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs, 2009.
- ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability (11) of electrically powered wheelchairs, 2008.
- (12) ISO 7176-11 Wheelchairs - Wheelchairs - Part 11: Test dummies, 2012.
- (13) ISO 7176-13 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. 1989.
- (14) ISO 7176-14 : Power and control system for electric wheelchairs, 2008.
- ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, (15) documentation and labelling, 1996.
- (16) ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
- (17) ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.
6
Image /page/6/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 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. The image also includes the TÜV CERT and ISO-9001 CERTIFICATED logos.
Biocompatibility information
Patient contacting materials: Seat PVC material, Hand grip PVC material, Seat belt PVC material
We tested these patient contacting materials for compliance to the standards ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. We provide the FDA Form 3654 for these standards.
7
Image /page/7/Picture/0 description: The image shows a logo with a butterfly design. The butterfly is purple and is set against a blue square. Below the butterfly is the word "HEARTWA" in bold, black letters. A yellow line extends from the left of the word "HEARTWA" and has a circle at the top.
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 Web : www.heartway.com.tw 60
E-mail : sales@heartway.com.tw
CERTIFICATED
P
TÜV-
COMPARISON TABLE
Similarities
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | Safety and
effectiveness of
subject device
compared to the
predicate device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| BRAND NAME | HEARTWAY | HEARTWAY | Same brand |
| MANUFACTURER | HEARTWAY Medical Products Co., Ltd. | HEARTWAY Medical Products Co., Ltd. | Same manufacturer |
| MODEL NO | S34 | BRIO S19 | Different model |
| 510K NO | K101142 | TBA | Different submission |
| SERIES | Lightweight Power
Mobility Scooter Series | Power Mobility
Scooter series | Lighter scooter
weight design |
| INTENDED USE | The device is intended for
medical purposes to
provide mobility to
persons restricted to a
sitting position. | The device is intended for
medical purposes to provide
mobility to persons restricted
to a sitting position. | Same intended use
and target population |
| Weight limit | 100 kgs / 220 lbs | 100 kgs / 220 lbs | Same weight |
| Electronics
controller | Penny & Giles
S-Drive | Penny & Giles
S-Drive | Same controller |
| Motor | 3A 24V, 270W @1 | 3A 24V, 270W @1 | Same motor type |
| Footplates | ABS | ABS | Same footplate
material |
8
Image /page/8/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a purple butterfly-like shape against a blue square. The word HEARTWAY is written in bold, black letters below the square. A yellow line connects the left side of the word HEARTWAY to a yellow circle.
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 Web : www.heartway.com.tw പ
60
Image /page/8/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email address is preceded by the text "E-mail :". The text is in a sans-serif font and is black. The background is white.
Image /page/8/Picture/8 description: The image contains two logos. The first logo is the "TUV CERT" logo, which is a blue stamp with the words "TUV" on top and "CERT" on the bottom. The second logo is the "ISO-9001 CERTIFICATED" logo, which is a rounded rectangle with the words "ISO-9001" on top and "CERTIFICATED" on the bottom. Both logos are associated with quality and certification.
ಲ್ಲಿ
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | Safety and
effectiveness of
subject device
compared to the
predicate device |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Suspension | Cross brace | Cross brace | Same |
| Back upholstery | Fabric | Fabric | Same |
| Wheel Lock | Push-to-Lock | Push-to-Lock | Same |
| Warranty | 3 years: Main frame
1 years: Controller / gear motor /
batteries w/o exhaustive and
wear parts | 3 years: Main frame
1 years: Controller / gear motor /
batteries w/o exhaustive and wear
parts | Same |
| Batteries | | | |
| Quantity | Two | Two | Same battery |
| Type | 12Ah /12VDC | 12Ah /12VDC | |
| Patient contacting
materials | Seat PVC material
Hand grip PVC material
Seat belt PVC material | Seat PVC material
Hand grip PVC material
Seat belt PVC material | Same PVC
materials |
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | Safety and
effectiveness of
subject device compared to the
predicate device |
| Overall dimension
Overall length
Overall width
Overall height | 995 mm / 39.0"
490 mm / 19.3"
940 mm / 37.0" | 930 mm / 36.6"
485 mm / 19.0"
945 mm / 37.2" | Smaller dimensions |
| Armrest types | Flip-backward | No armrest | No armrest for subject device |
| Frame | Fixed / carbon steel | Fixed / Aluminum alloy | Lighter frame material |
| Seat dimension
Seat width
Seat height | 570 mm / 22.5"
408 mm / 16" | 395 mm / 15.5"
350 mm / 13.75" | Smaller dimensions |
| Rear wheels | 8" x 3" solid x 2 | 8" x 2" solid x 2 | Thinner tires |
| Front casters | 8" x 3" solid x 2 | 7" x 1.6" solid x 2 | Smaller tires |
| Turning Radius | 950 mm / 37.4" | 820 mm / 32.2" | Smaller radius |
| Ground clearance | 70 mm / 2.8" | 60 mm / 2.3" | Smaller clearance |
| Kerb climbing
ability | 50 mm / 2.0" | 45 mm / 1.7" | Smaller kerb |
| Scooter weight | w/ batteries 43.6kgs / 96 lbs
w/o batteries 36.6kgs / 81 lbs | w/batteries 31.3kgs / 69 lbs
w/o batteries 24.0kgs / 53 lbs | Smaller weight |
| Maximum speed | 7.8 km/hr
(4.875 mile/h ) | 8.0 km/hr
(5.0 mile/h ) | Larger speed |
| Incline | 10 degrees | 6 degrees | Smaller angle |
| Range per full
charging | 1015 km / 69 miles | 18 km / 11.25 miles | Longer cruise range |
9
Image /page/9/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the text is a blue square with a stylized purple butterfly shape inside. To the left of the square, there is a yellow line with a small circle at the top, adding a design element to the logo.
HEARTWAY MEDICAL PRODUCTS CO.,LTD.
60
TÜV-GERT2
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 പ
E-mail : sales@heartway.com.tw
Differences:
10
| Image: HEARTWAY MEDICAL PRODUCTS CO.,LTD. logo and contact information | |||
|---|---|---|---|
| Battery Charger | External (off-board ) charger | External (off-board ) charger | Same type |
| Voltage output | 24VDC (UL E241359 ) | 24VDC (UL E201162) | different models |
| with same | |||
| voltage output | |||
| model | 4C24020A | 4C24050A | |
| Biocompatibility | ISO 10993-1:2009 | ||
| ISO 10993-5:2009 | ISO 10993-1:2009 | ||
| ISO 10993-5:2009 | |||
| ISO 10993-10:2010 | More testing |
COMPARISON DISCUSSION
The intended uses and the target populations for the two devices are the same. The weight limit 100kgs / 220lbs, P&G S-Drive electronic controller, the type of motor and batteries, suspension of cross brace, footplates, warranty of the components, the back upholstery material, and patient-contacting materials are the same. The back upholstery fabric passed the resistance ignition test in accordance with ISO 7176-16.
The electronic systems for two devices are the same and passed the UL certifications. Though battery charger and the competent components are different, they all passed the UL certifications. Thus the same safety levels for the two devices are assured.
There is one more biocompatibility testing ISO 10993-10:2010 for the subject device than the predicate device. This can ensure more safety and biocompatibility for the users.
There is no armrest for the subject device since it is designed for lighter and faster ways. Armrest is not a safety factor for users. No armrest leads to less weight and more compact size for BRIO S19 and the safety and effectiveness concerns are also ensured.
The major differences between the subject device and the predicate device are scooter weights and dimensions, due to the subject device BRIO S19 using lighter mainframe material of aluminum alloy than the carbon steel material used by predicate device. But both carbon steel and aluminum alloy materials all passed the strength and fatigue tests. The safety and effectiveness concerns are ensured.
11
Image /page/11/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, along with the company name in bold, black letters. The contact information includes 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).
We know work equals to force (= weight/9.8) times distance. The motor powers (=work/second) and the batteries are the same. So the subject device has larger cruise range per full charging than the predicate device since the subject device has lighter weight. In addition, it is also known that power equals to force times speed. For the same power, the force (weight/9.8) is inversely proportionally to the speed. So the subject device has larger maximum speed 8.0 km/hr (5.0mile/h) than the predicate device 7.8 km/hr (4.88 mile/hr) since BRIO S19 has lighter weight. In order to stand the larger scooter weight, the predicate device must have larger rear wheels and castors. For a larger rear wheels and castors of the predicate device, the turning radius is surely larger. This also leads to larger ground clearance and larger kerb climbing ability for the predicate device.
For a larger overall height and smaller seat height for the subject device, the center of weight with loaded user must be higher and the subject device must be less stable when moves on an incline. So: incline capabilities for subject device is 6° and for predicate device is 10°. But the safeties of both devices moving on the maximum inclined slopes were ensured by the ISO 7176-1 and ISO 7176-2 tests.
Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC 2, Section 21 for the EMC test. There are no safety and effectiveness aspects concerned. Thus, the two devices are substantially equivalent.
CONCLUSIONS
The subject device, HEARTWAY Power Mobility Scooter, BRIO S19, is as safe and effective as, and functions in a manner equivalent to the predicate device, HEARTWAY Lightweight Power Mobility Scooter S34. 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 device.