(213 days)
Not Found
No
The description focuses on torque sensors and adjustable assist power, with no mention of AI or ML algorithms for interpreting user intent or optimizing assistance.
No.
The device assists the user in operating a manual wheelchair to expand their field of activities, but it does not treat or diagnose a disease or condition in a therapeutic manner.
No
The device is a "Power Assist Wheelchair Conversion Kit" that provides assistance to manual wheelchair users. Its function is to convert a manual wheelchair into a power-assisted one by supplying assist power, not to diagnose medical conditions or analyze biological samples.
No
The device description explicitly states it consists of physical components like power wheel units, battery chargers, and torque sensors, which are hardware.
Based on the provided information, the device JWX-2 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist manual wheelchair users with mobility by providing power assistance. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical and electrical system that modifies a wheelchair's operation. It does not mention any components or processes related to analyzing biological specimens (blood, urine, tissue, etc.).
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The JWX-2 is clearly a medical device designed to improve mobility, falling under the category of assistive technology or durable medical equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The device JWX-2 is an electric power assist unit for wheelchairs that turns a manual wheelchair into a power assisted wheelchair. The device supplies the assist power in response to the wheelchair handrim operating both push-and-brake forces in both directions. The user can operate the wheelchair just like a manual wheelchair with lighter hand force.
The device consists of the left/ right power wheel units, battery charger. The power wheel units replace the original wheels of the manual wheelchair. Each power wheel unit has its own hand rim that incorporates the torque sensor which detects the user's operation force. Yamaha Ni-MH battery JWB2 and Yamaha Li-ion battery ESB1 can be used for the device. JWB2 is recharged with the charger JWC-2 and ESB1 is recharged with the charger ESC1. Both batteries can be charged in detached 'desktop' condition and the ESB1 can be charged also on the wheelchair condition. ESB1 does not supply the driving current during the charging to prevent the wheelchair to move.
The assist power of the device is adjustable.
The wheel locks of the manual wheelchair can be used to prevent the wheelchair from rolling and to keep the wheelchair complete stop like manual wheelchairs with the initial installation adjustment.
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)
The device JWX-2 was tested with the following standards:
ISO 7176-9: Third edition 2009-11-15, Wheelchairs - Part 9: Climatic tests for electric wheelchairs.
ISO 7176-14: 2008, Wheelchairs - Part 14: Power and control system for electrically powered wheelchairs and scooters – Requirements and methods.
ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-21:2009, Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers.
IEC 62304 First edition 2006-05, Medical device software: Software life cycle processing
ISO 14971 Second edition 2007-03-01, Medical devices Application of risk management to medical devices.
AAMI / ANSI / ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. (Biocompatibility)
AAMI/ANSI/ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for In Vitro cytotoxicity.
IEC 60335-2-29:2002(Fourth edition)+A1:2004 , Household and similar electrical appliances - Safety - Part 2-29: Particular requirements for battery chargers
IEC60335-1:2001(Fourth edition)+A1:2004+A2:2006 , Household and similar electrical appliance - Safety - Part 1: General requirements
IEC 62133:2012 , Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
AAMI / ANSI / IEC 60601-1-2, medical electrical equipment - part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests (edition 2:2001 with amendment 1:2004) (aami/ansi/iec 60601-1-2:2001 with amendment 1:2004 is the u.s.. (General I (QS/RM))
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble hair or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Yamaha Motor Company, Limited c/o Mr. Alexander Schapovalov TÜV SÜD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
Re: K140204
Trade/Device Name: JWX-2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 26, 2014 Received: July 27, 2014
Dear Mr. Schapovalov:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Aquel -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
2
Indications for Use
510(k) Number (if known) K140204
Device Name JWX-2
Indications for Use (Describe)
The device JWX-2 is a Power Assist Wheelchair Corversion Kit and sutable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of assisting their wheelchair operating force.
Type of Use (Select one or both, as applicable)
X 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)
2014-08-28 43 -04'00
3
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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:
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"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."
4
5. 510(k) SUMMARY
| 1. Submitter information | |||
|---|---|---|---|
| Manufacture Name: | YAMAHA MOTOR CO.,LTD. | ||
| 882 Soude,Naka-ku | |||
| Hamamatsu, Shizuoka 435-0054, Japan | |||
| Contact Person: | Masanori YONEMITSU , General Manager | ||
| JW Wheelchairs Division , IM Operations | |||
| YAMAHA MOTOR CO.,LTD. | |||
| Tel: +81-53-460-6167 | |||
| Fax: +81-53-460-6146 | |||
| E-mail: yonemitsum@yamaha-motor.co.jp | |||
| 2. Date Prepared | October 21, 2013 | ||
| 3. Device | Type in common name: | ||
| Name: | |||
| Classification Name: | |||
| Product Code: | |||
| Device Structure: | Electric Power Assist Unit for Wheelchairs | ||
| JWX-2 | |||
| Wheelchair, Powered (21 CFR 890.3860) | |||
| ITI | |||
| Right Power Wheel Unit | |||
| Left Power Wheel Unit | |||
| Battery | |||
| Battery Charger | |||
| 4. Basis for the Submission: | New device design | ||
| 5. Predicate Device: | SUNRISE MEDICAL, INC. | ||
| QUICKIE 2 POWER ASSIST WHEELCHAIR(K001491) | |||
| Urich Alber GmbH & Co. KG | |||
| e-motion Wheelchair Drive System (K003449) |
- Device Description
The device JWX-2 is an electric power assist unit for wheelchairs that turns a manual wheelchair into a power assisted wheelchair. The device supplies the assist power in response to the wheelchair handrim operating both push-and-brake forces in both directions. The user can operate the wheelchair just like a manual wheelchair with lighter hand force.
The device consists of the left/ right power wheel units, battery charger. The power wheel units replace the original wheels of the manual wheelchair. Each power wheel unit has its own hand rim that incorporates the torque sensor which detects the user's operation force. Yamaha Ni-MH battery JWB2 and Yamaha Li-ion battery ESB1 can be used for the device. JWB2 is recharged with the charger JWC-2 and ESB1 is recharged with the charger ESC1. Both batteries can be charged in detached 'desktop' condition and the ESB1 can be charged also on the wheelchair condition. ESB1 does not supply the driving current during the charging to prevent the wheelchair to move.
The assist power of the device is adjustable.
The wheel locks of the manual wheelchair can be used to prevent the wheelchair from rolling and to keep the wheelchair complete stop like manual wheelchairs with the initial installation adjustment.
5
7. Indications for use
The device JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
8. Comparison to Predicate Devices
The device has the similar technological characteristics as the predicate device. The microprocessors in both devices control the electrical current from the rechargeable batteries to the wheel-in motors in response to the user's handrim operations. Both devices use a mix of human and electrical power to propel the wheelchair and can be used with the device power turned off like a manual wheelchairs. See COMPARISON TABLE below.
9. Non-Clinical Testing
The device JWX-2 was tested with the following standards
| ISO 7176-9: Third edition 2009-11-15, Wheelchairs - Part 9:
| Climatic tests for electric wheelchairs. |
|---|
| ISO 7176-14: 2008, Wheelchairs - Part 14: |
| Power and control system for electrically powered wheelchairs and scooters |
| – Requirements and methods. |
| ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: |
| Requirements for information disclosure, documentation and labeling |
| ISO 7176-21:2009, Wheelchairs - Part 21: |
| Requirements and test methods for electromagnetic compatibility of electrically powered |
| wheelchairs and scooters, and battery chargers. |
| IEC 62304 First edition 2006-05, Medical device software: |
| Software life cycle processing |
| ISO 14971 Second edition 2007-03-01, Medical devices |
| Application of risk management to medical devices. |
| AAMI / ANSI / ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: |
| Evaluation and testing within a risk management process. (Biocompatibility) |
| AAMI/ANSI/ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: |
| Tests for In Vitro cytotoxicity. |
| IEC 60335-2-29:2002(Fourth edition)+A1:2004 , Household and similar electrical appliances |
- Safety - Part 2-29: Particular requirements for battery chargers |
| IEC60335-1:2001(Fourth edition)+A1:2004+A2:2006 , Household and similar electrical appliance - Safety - Part 1: General requirements |
| IEC 62133:2012 , Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them,
for use in portable applications |
AAMI / ANSI / IEC 60601-1-2, medical electrical equipment - part 1-2:
general requirements for safety - collateral standard: electromagnetic compatibility
- requirements and tests (edition 2:2001 with amendment 1:2004)
(aami/ansi/iec 60601-1-2:2001 with amendment 1:2004 is the u.s.. (General I (QS/RM))
10. Summary
The device JWX-2 has the same intended use and similar technological characteristics as the predicate device. The device does not raise any new questions of safety or effectiveness. The device is substantially equivalent to the predicate device.
6
| | QUICKIE 2 POWER ASSIST
WHEELCHAIR | E-MOTION WHEELCHAIR
DRIVE SYSTEM | JWX-2 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K001491 | K003449 | Subject Device |
| Intended Use | Quickie powered
wheelchairs empower
physically challenged
persons by providing a
means of enhanced mobility. | The e-motion Wheelchair
Drive System is a Power
Wheelchair Conversion Kit
that adds a power assist to a
manual wheelchair, thereby,
turning a manual
wheelchair into a power-
assisted wheelchair. It is a
push-and-brake assist
working in both directions.
The intended use is to
provide mobility to persons
limited to a seated position
that are capable of operating
a powered and manual
wheelchair. | The device JWX-2 is a
Power Assist Wheelchair
Conversion Kit and suitable
for the manual wheelchair
users who are limited in their
field of activities because of
their physical conditions. The
device can expand their field of activities by assisting their
wheelchair operating force. |
| Total Weight | 15.8kg(Ni-MH) | 22kg(Li-ion) | 17 kg (Ni-MH)
17.7kg (Li-ion) |
| Drive Unit Width
(Hub Height) | 95mm | 93mm | 91mm
*There is no influence on
stability. Rather, a user can
go also to a narrower place. |
| Max. User Weight | 120kg | 130kg | 130kg |
| Speed Range with
Power Assist | up to 6Km/h | up to 6km/h | up to 6Km/h |
| Max Safe Slope | 6° | 6° | 6° |
| Max Range per Charge | 15km & above (Ni-MH) | 25km & above | 40km & above (Li-ion)
20km & above (Ni-MH)
*More range per charge is
benefitial for end users. |
| Type of Motor | DC Brush Motor | DC Brushless Motor | AC servomotor
(DC Brushless Motor) |
| Rated Power of Motor | 30mins rated 90W x 2 | DC24V 60W×2 | 30mins rated 110W x 2 |
| Battery | Type: Ni-MH(Dry)
Capacity: 24V 6.7Ah(Nom.) | Type: Li-ion
Capacity: 25.2V 6.45Ah x 2 | Type: Ni-MH(Dry)
Capacity: 24V 6.7Ah(Nom.)
Type: Li-ion(Dry)
Capacity:
25V11.8Ah(Nom.)
*Selectable |
| | QUICKIE 2 POWER ASSIST
WHEELCHAIR | E-MOTION WHEELCHAIR
DRIVE SYSTEM | JWX-2 |
| Wheel Size | 24"/22" | 24"/22" | 24"/22" |
| Tire | Pneumatic | Pneumatic | Pneumatic |
| Quick Release Axle | QR only | QR only | QR only |
| Left/Right wheel | Provided | N/A | Provided |
| Synchronized Control | Provided | Individual control | Provided |
| Regenerative Brake | Provided | Provided | Provided |
| Down Slope Speed
Regulation | Provided | N/A | Provided |
| Driving Mode Selector
(user operable) | N/A | M15: 2 power stages
with remo-cont
'r M14: preset only | Option
(2 modes) |
| Handrim | - Stainless steel
- Dipped Vinyl Coated | - Stainless steel
- Dipped Vinyl Coated
- Removable rubber cover | - Stainless steel
- Dipped Vinyl Coated |
| Certification | EN12184:2009
(Electrically powered
wheelchairs, scooters and
their chargers -
Requirements and test
methods)
- Power assist component
(JW-II) supplied by
YAMAHA MOTOR is
certificated
by TUV SUD. | EN12184:1999
(Electrically powered
wheelchairs, scooters and
their chargers -
Requirements and test
methods)
by TUV SUD | EN12184:2009
(Electrically powered
wheelchairs, scooters and
their chargers -
Requirements and test
methods)
by TUV SUD |
7
COMPARISON TABLE(continued)
(Same performance are indicated by boldface.)