JWG-1

K252101 · Yamaha Motor Co., Ltd. · ITI · Mar 19, 2026 · Physical Medicine

Device Facts

• Record ID: K252101
• Device Name: JWG-1
• Applicant: Yamaha Motor Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 19, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device JWG-1 is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

Device Story

JWG-1 is a powered wheelchair conversion kit; transforms manual wheelchairs into powered wheelchairs. System comprises left/right drive units, controller, Li-ion battery (JWB3), and charger (JWC4). Drive units replace original manual wheels. Operated by the user to control propulsion. Used in various environments to assist mobility for individuals with walking impairments. Battery charging occurs in detached or on-chair states; charging mode inhibits driving current for safety. Provides motorized assistance to reduce physical effort for the user.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including static/dynamic stability (ISO 7176-1, -2), braking effectiveness (ISO 7176-3), energy consumption (ISO 7176-4), speed/acceleration (ISO 7176-6), structural strength (ISO 7176-8), climatic testing (ISO 7176-9), power/control systems (ISO 7176-14), electromagnetic compatibility (ISO 7176-21), and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

Powered wheelchair conversion kit. Components: drive units, controller, Li-ion battery, charger. Standards: ISO 7176 series (stability, brakes, energy, speed, strength, climate, power/control, EMC), ISO 10993 series (biocompatibility). Battery charging safety interlock prevents movement during charge. Electrical power system.

Indications for Use

Indicated for disabled persons unable to walk or with walking restrictions requiring powered propulsion for increased mobility and flexibility.

Regulatory Classification

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.

Predicate Devices

• JWX-1 PLUS (K203806)
• e-fix E35/E36 (K161241)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 19, 2026

Yamaha Motor Co., Ltd
Yasutoshi Morikawa
General Manager
2500, Shingai
Iwata city, Shizuoka 4388501
Japan

Re: K252101
Trade/Device Name: JWG-1
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: February 17, 2026
Received: February 17, 2026

Dear Yasutoshi Morikawa:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252101 - Yasutoshi Morikawa
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K252101 - Yasutoshi Morikawa
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Sincerely,

Digitally signed by
MARY S. KESZLER -S
Date: 2026.03.19
09:03:38 -04'00'

for Tushar Bansal, PhD
Acting Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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JWG-1
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252101 | ? |
| Please provide the device trade name(s). | | ? |
| JWG-1 | | |
| Please provide your Indications for Use below. | | ? |
| The device JWG-1 is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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510(k) #: K252101
510(k) Summary
Prepared on: 2026-03-18

## Contact Details
21 CFR 807.92(a)(1)

| Applicant Name | Yamaha Motor Co., Ltd |
| --- | --- |
| Applicant Address | 2500, Shingai Iwata city Shizuoka 4388501 Japan |
| Applicant Contact Telephone | [phone] |
| Applicant Contact | Mr. Yasutoshi Morikawa |
| Applicant Contact Email | [e-mail] |

## Device Name
21 CFR 807.92(a)(2)

| Device Trade Name | JWG-1 |
| --- | --- |
| Common Name | Powered wheelchair |
| Classification Name | Wheelchair, Powered |
| Regulation Number | 890.3860 |
| Product Code(s) | ITI |

## Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K203806 | JWX-1 PLUS | ITI |
| K161241 | e-fix E35/E36 | ITI |

## Device Description Summary
21 CFR 807.92(a)(4)

The JWG-1 is an add-on drive for wheelchairs. The JWG-1 turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

The device consists of the left/right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.

Yamaha Li-ion battery JWB3 can be used for the device. They are recharged with the charger JWC4. Battery can be charged in detached 'desktop' condition and on the wheelchair condition. JWB3 does not supply the driving current during the charging to prevent the wheelchair to move.

## Intended Use/Indications for Use
21 CFR 807.92(a)(5)

The device JWG-1 is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

## Indications for Use Comparison
21 CFR 807.92(a)(5)

The indications for use are the same.

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Technological Comparison
21 CFR 807.92(a)(6)

The indications for use are the same.

# Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The subject device was tested with the following standards:

ISO 7176-1:1999, Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2001, Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3 Third edition 2012-12-15, Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4 Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range ISO
7176-6 Second edition 2001-10-01, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-8:1998, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9 Third edition 2009-11-15, Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-11 Second edition 2012-12-01, Wheelchairs - Part 11: Test dummies
ISO 7176-14 Second edition 2008-02-15, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15 First edition 1996-11-15, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-21 Second edition 2009-04-01, Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 10993-1 Fifth edition 2018-10, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10 Third edition 2010-08-01, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Clinical Test results of JWG-1 were not used to establish substantial equivalence.

The device JWG-1 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.

JWG-1
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