(306 days)
Not Found
No
The device description and performance studies focus on standard power wheelchair functionality and safety standards, with no mention of AI/ML.
No
The device provides mobility to individuals, which is a supportive function rather than actively treating a medical condition or restoring damaged tissues or functions.
No
The intended use of the device is to provide mobility. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly outlines a physical power wheelchair with a base, wheels, seat, armrests, and hand controls. The performance studies listed are all related to the physical characteristics and performance of a wheelchair, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "medical purposes to provide mobility to persons restricted to a seated position." This describes a device used on a patient for a physical function, not a device used to test samples from a patient to diagnose or monitor a condition.
- Device Description: The description details a power wheelchair, which is a mobility aid. It doesn't 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:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic or monitoring information based on sample analysis
- Mentioning any laboratory or clinical testing procedures
The performance studies listed are all related to the physical and electrical performance of a wheelchair, 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)
ITI
Device Description
The HEARTWAY Power Wheelchair, P25 is an indoor / outdoor power chair that is It has a base with four-wheeled with a seat, and armrests. battery operated. The movement of the power chair 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 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: 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, 2003.
-
- 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, 1992.
-
- 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.
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo with a stylized floral design above the word "HEART-WAY" in bold, block letters. The floral design is composed of four petal-like shapes arranged in a circular pattern, set against a square background. A thin vertical line extends upwards from the left side of the word "HEART-WAY", terminating in a small circle.
HEARTWAY MEDICAL PRODUCTS CO
NO.6, ROAD 26, 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
E-mail salatumcharncomte !
t
ISO-9001
CERTIFICATED
510(k) SUMMARY " 66
K132856
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 40850, Taiwan, ROC
Date summary prepared: Device Name:
July 15, 2014
| Proprietary Name: | HEARTWAY Power Wheelchair, P25 |
|---|---|
| Common or Usual Name: | POWERED WHEELCHAIR |
| Classification Name: | POWERED WHEELCHAIR, Class II, |
| 21 CFR 890.3860 | |
| Product Code: | ITI |
| Name of Contact Person: | Dr. Jen, Ke-Min |
| Tel: +886-4-23580357 Fax: +886-3-5209783 | |
| Email:ceirs.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 Wheelchair, P25 is an indoor / outdoor power chair that is It has a base with four-wheeled with a seat, and armrests. battery operated. The movement of the power chair 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 charger.
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.
1
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized floral design above the word "HEART-WA". The floral design consists of four rounded petals arranged in a circular pattern, set against a square background. A thin vertical line extends upwards from the left side of the word "HEART-WA", terminating in a small circle.
HEARTWAY MEDICAL PRODUCTS CO.,L
NO.6, ROAD 26. 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
Image /page/1/Picture/3 description: The image shows a logo with the text "TUV CERT" in a stylized font. The logo is surrounded by a circular border. Below the logo, there is a rectangular box with rounded corners, but the text inside is not legible. The image appears to be a certification mark or quality assurance symbol.
- ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes, 2003.
-
- 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, 1992.
-
- 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 120 kgs / 265 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:
2
Image /page/2/Picture/0 description: The image shows a logo with a stylized butterfly or flower design above the word "HEARTWA". The butterfly/flower is black and is set against a black square. The word "HEARTWA" is in a bold, sans-serif font. The image is black and white.
HEARTWAY MEDICAL PRODUCTS CO.
TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN 95 - 23583232 (Rep) FAX:886-4-23590786
- Sand surface .
- Wet or icy surface
- Road maintenance hole metal cover
- Too steep incline over 10 degrees.
- . Turning Radius 650 mm / 25.6"
- Ground clearance 80 mm / 3,2"
- Curb climbing ability 75 mm / 3.0"
Compare to the legally marketed device for substantial equivalence: Predicate Device: HEARTWAY Power Chair, P23 (K100327)
Summary for substantial equivalence comparison:
The indications for use between the two devices are the same. Mainframes of two devices are folded and they use the same material. The mainframe materials of the two devices all meet the strength and fatigue tests. The incline capabilities. cross brace suspension, footplates, armrest type, and the warranty are all the same. The back upholstery material is also made of the same fabric and passes the ignition-resistance test in accordance with ISO 7176-16.
Specifically, the electronic systems for two devices are the same controller, i.e., P & G VR2, and are from the same suppliers. The electronic controller, batteries, recharger, and the competent switches and switching power supplies all pass the UL certification. Thus the same safety and effectiveness levels for the two devices are assured.
The main differences for the two devices are overall dimensions. Therefore, the weight limit, cruising range, maximum speed, wheelchair weight, the sizes of wheels and seat, and the relevant specifications for ground clearance and curb climbing ability are different. But two devices all meet the ISO 7176 series standards requirements. Thus for the real-life use instead of different dimensional specifications, the two devices are substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows a logo for HEART-WAY. The logo features a stylized heart shape with four lobes, resembling a flower or clover. The word "HEART-WAY" is printed in bold, sans-serif letters below the heart shape. The image appears to be a cropped section from a larger document or advertisement.
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 - : •
Image /page/3/Picture/3 description: The image contains two logos. The first logo is the "TUV CERT" logo, which is a certification mark. The second logo is the "ISO-9001 CERTIFICATED" logo, which indicates that the organization is certified to the ISO 9001 standard. The year 2005 and the Japanese word "本当時代" are also present in the image.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E-mail : sales@heartway.com : w ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Comparison Table _
Similarities:
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE |
|---|---|---|
| BRAND NAME | HEARTWAY | |
| MANUFACTURER | HEARTWAY Medical Products Co., Ltd. | |
| SERIES | Power Wheelchair System Series | |
| MODEL NO | P23 | P25 |
| 510K NO | K100327 | K132856 |
| INTENDED USE | The device is intended for | |
| medical purposes to | ||
| provide mobility to persons | ||
| restricted to a sitting | ||
| position. | Same | |
| Frame | Folded | Same |
| Electronics | P & G, VR2 | |
| controller | Same | |
| Suspension | Cross brace | Same |
| Footplates | ABS | Same |
| Incline | 10 degrees | Same |
| Back Upholstery | Fabric | Same |
| Armrest Types | Flip-backward | Same |
| Recharger | 24VDC | |
| (UL 1310 certified) | Same | |
| Wheel Lock | Push-to-Lock | Same |
| Warranty | 3 years: Main frame | |
| 1 years: Controller / gear motor / | ||
| batteries w/o exhaustive and | ||
| wear parts | Same | |
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE |
| Overall Dimension | ||
| Overall length | 1100 mm / 43.3" | 830 mm / 32.7" |
| Overall width | 660 mm / 26.0" | 650 mm / 25.6" |
| Overall height | 1100 mm / 43.3" | 1060 mm / 41.7" |
| Weight Limit | 135 kgs / 300 lbs | 120 kgs / 265 lbs |
| Maximum Speed | 6.0 km/hr ( 3.8mile/h ) | 9.6 km/hr ( 6.0mile/h ) |
| Batteries | ||
| Quantity | Two | Two |
| Type | 34Ah 12VDC | 50Ah 12VDC |
| Range per charge | 26~30km / 18 miles | 35km / 22 miles |
| Rear Wheels | 10" x 3.3" solid x 2 | 14" x 3.0" solid x 2 |
| Casters | 6.0" x 2" solid x 2 | 10" x 3.3" solid x 2 |
| Seat Size | ||
| Width | 66 cm / 26.0" | 48 cm / 18.9" |
| Length | 85 cm / 33.5" | 44 cm / 17.3" |
| Height | 30 cm / 11.8" | 53 cm / 20.9" |
| Turning Radius | 550 mm / 21.7" | 650 mm / 25.6" |
| Ground Clearance | 75 mm / 3.0" | 80 mm / 3.2" |
| Curb Climbing | ||
| Ability | 60 mm / 2.4" | 75 mm / 3.0" |
| Wheelchair Weight | w/i batteries 85kgs / 187 lbs | |
| w/o batteries 60kgs / 132 lbs | w/i batteries 125kgs / 276 lbs | |
| w/o batteries 75kgs / 165 lbs |
4
Image /page/4/Picture/0 description: The image shows a logo for HEART-WAY. The logo consists of a stylized flower or leaf design in black, positioned above the word "HEART-WAY" in bold, black letters. The flower design is abstract, with rounded shapes forming a petal-like structure.
HEARTWAY MEDICAL PRODUCTS CO.,LTD.
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:888-4-23580357 (Sales)·23583232 (Rep) FAX:886-4-23590786 Wab : www.heartway.com.tw
Image /page/4/Picture/3 description: The image contains a logo for "TUV CERT". The logo consists of the letters "TUV" stacked on top of the word "CERT", and the entire wordmark is surrounded by two concentric circles. The logo is black and white.
CERTERCATED
E-mail : sales@heartway.com.w
Differences:
5
Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2014
HEARTWAY Medical Products Co., Ltd. c/o Dr. Jen. Ke-Min No. 6 Road 25, Taichung Industrial Park Taichung, 40850 Taiwan, ROC
Rc: K132856
Trade/Device Name: HEARTWAY Power Wheelchair. P25 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 5, 2014 Received: June 12, 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. 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
Image /page/5/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized with three curved lines representing its wings and body.
6
Page 2 - Dr. Jen, Ke-Min
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/ResourcesforYou/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 Aguel - S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132856
Device Name
HEARTWAY Power Wheelchair, P25
Indications for Use (Describe)
This 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)
[x] 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)
:15 -S Date: 2014.07.15
17:47:42 -04'00'
8
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."