Manual Wheelchair (MS01);Manual Wheelchair (MA01)
Device Facts
| Record ID | K261075 |
|---|---|
| Device Name | Manual Wheelchair (MS01);Manual Wheelchair (MA01) |
| Applicant | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Jun 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
Indications for Use
Manual wheelchair (model:MS01,MA01) is intended for medical purpose to provide mobility to persons limited to a sitting position.
Device Story
Manual wheelchair (models MS01, MA01) provides mobility to users limited to a sitting position. Device features steel or aluminum frame, 24-inch rear wheels with hand rims for patient self-propulsion, 8-inch front swivel castors, flip-back armrests, and adjustable footrests. Operated by patient or caregiver in various settings. Provides postural support via padded back and seat upholstery; includes manual brakes to immobilize device during transfers. Benefits include improved mobility and postural stability for users up to 136 kg.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Manual, foldable wheelchair. Frame: steel or aluminum. Dimensions: 1090mm L x 610mm W x 920mm H. Features: 24" rear wheels, 8" front castors, manual brakes, flip-back armrests, adjustable footrests. Standards: ISO 7176-1, -3, -5, -7, -8, -11, -13, -15; ISO 16840-10 (flammability); ISO 10993-5, -10, -23 (biocompatibility).
Indications for Use
Indicated for persons limited to a sitting position requiring mobility assistance. Contraindicated for: overloading beyond 136 kg; use as motor vehicle seat; use on escalators; use on gradients exceeding 10°; multi-occupancy; standing on footrests; leaning/pushing on push handles; lifting via detachable components; or loading back upholstery storage bag with >5 kg.
Regulatory Classification
Identification
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Predicate Devices
- MA012 Aluminum wheelchair, MS019 Steel wheelchair (K231750)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 22, 2026
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
Sally Peng
Official Correspondent
#39, Baozhu E. Rd., Huangpu Town
Zhongshan, Guangdong 528400
China
Re: K261075
Trade/Device Name: Manual Wheelchair (MS01); Manual Wheelchair (MA01)
Regulation Number: 21 CFR 890.3850
Regulation Name: Mechanical Wheelchair
Regulatory Class: Class I, reserved
Product Code: IOR
Dated: March 31, 2026
Received: April 1, 2026
Dear Sally Peng:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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" (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-
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K261075 - Sally Peng
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by
MARY S. KESZLER -S
Date: 2026.06.22
15:03:12 -04'00'
for Tushar Bansal, PhD
Acting Assistant Director
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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# 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. | K261075 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Manual Wheelchair (MS01); Manual Wheelchair (MA01) | | |
| Please provide your Indications for Use below. | | ? |
| Manual wheelchair (model:MS01,MA01) is intended for medical purpose to provide mobility to persons limited to a sitting position. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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Traditional 510(k) Submission of Manual Wheelchair
# 510(K) Summary - K261075
Prepared in accordance with the requirements of 21 CFR Part 807.92
**Prepared Date:** March 20,2026
## 1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
| --- | --- |
| Address: | No.39, Baozhu East Road, Huangpu Town, Zhongshan City, Guangdong, China. |
| Contact person: | Sally Peng |
| Title: | Manager |
| E-mail: | sally@yongyicn.com |
| Tel: | 86-760-23235999 |
## 2. Device Identification
| 510(K) number: | |
| --- | --- |
| Trade/Device Name: | Manual Wheelchair |
| Models: | MS01,MA01 |
| Common name: | Manual Wheelchair |
| Regulation Number: | 21CFR 890.3850 |
| Regulation Name: | Mechanical wheelchair |
| Regulation Class: | Class 1 |
| Panel: | Physical Medicine |
| Product Code: | IOR |
| Manufacturer: | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
## 3. Predicate Device
| 510(K) number: | K231750 |
| --- | --- |
| Trade/Device Name: | MA012 Aluminum wheelchair, MS019 Steel wheelchair |
| Models: | MA012,MS019 |
| Common name: | Manual Wheelchair |
| Regulation Number: | 21CFR 890.3850 |
| Regulation Name: | Mechanical wheelchair |
| Regulation Class: | Class 1 |
| Panel: | Physical Medicine |
| Product Code: | IOR |
| Manufacturer: | Sichuan Ast Medical Equipment Co., Ltd. |
510(k) Summary - K261075
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Traditional 510(k) Submission of Manual Wheelchair
#### **4. Indication for Use**
Manual wheelchair (model:MS01,MA01) is intended for medical purpose to provide mobility to persons limited to a sitting position.
#### **5. Device Description**
Manual wheelchair (model:MS01,MA01) is intended for medical purpose to provide mobility to persons limited to a sitting position. The Manual wheelchair (model:MS01,MA01) can not only be controlled, steered, and operated by professional caregivers, but also be propelled by the patient using the hand rims on both sides.
Manual wheelchair (model:MS01,MA01) is contraindicated for overloading beyond the specified maximum occupant mass of 136 kg; it is strictly contraindicated for use as a motor vehicle seat, on escalators, and on gradients exceeding 10° (including reversing down any gradient). The device is contraindicated for multi-occupancy use, and standing on the footrests, leaning or pushing down on the push handles, and lifting the wheelchair via push handles or detachable components for ascending/descending steps are all contraindicated. Additionally, the back upholstery storage bag is contraindicated for loading with items exceeding 5 kg, which may cause tipping. Any unauthorized use is prohibited.
The wheelchair is designed with two 24' rear wheels with hand rim, and can be manually moved forward and in reverse.
Wheelchair frames are made of either steel or aluminum. Frame serves as the primary structural chassis of the device, providing the foundational support, mechanical integrity, and overall dimensional form to the wheelchair assembly. It dictates the essential geometry and foldability of the device.
The back upholstery is a padded surface mounted on the rear pillar of the vehicle frame. Its function is to provide postural support to the user's back and pelvis, distribute pressure.
The seat upholstery is to provide seating interface for the user, contributing to pressure distribution and postural stability.
Armrest is a horizontally oriented support pad mounted laterally to the frame. It functions to support the user's forearm and elbow, aid in upper body stability and posture.
Footrests and foot plate are adjustable, cantilevered support structure extending from the lower front frame. The function is to provide a stable, ergonomic platform.
Brake is to securely immobilize the wheelchair by preventing rotation of the rear wheel, thereby stabilizing the device during stationary periods such as user transfers from wheelchair.
Castors are 8 inches in size, swiveling wheel assembly mounted at the front of the frame. The functions are to provide directional stability during straight-line travel, facilitate tight-radius turns by
510(k) Summary - K261075
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Traditional 510(k) Submission of Manual Wheelchair
pivoting.
The wheelchair can support users of up to 136 kg.
## 6. Compared to Predicate Device
Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table
| SE Comparisons | Subject Device Manual Wheelchair (Model: MS01,MA01) | Predicate Device MA012 Aluminum wheelchair, MS019 Steel wheelchair (Model: MA012,MS019:) | Similarities/ Differences |
| --- | --- | --- | --- |
| 510(K) number | / | K231750 | / |
| Indication for Use | MS01/MA01 manual wheelchair is intended for medical purpose to provide mobility to persons limited to a sitting position. | MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position. | Same |
| Product code | IOR | IOR | Same |
| Class | I | I | Same |
| Regulation Number | 21 CFR 890. 3850 | 21 CFR 890.3850 | Same |
| Common name | Mechanical Wheelchair | Mechanical Wheelchair | Same |
| Type of Use | Over the Counter (OTC Only) | Over the Counter (OTC Only) | Same |
| Device Length | 1090 mm | MA012: 950mm MS019: 916mm | Different See Note 1 |
| Device Width | 610mm | MA012:610mm MS019:574mm | Different See Note 1 |
| Device Height | 920mm | MA012:970mm MS019:896mm | Different See Note 1 |
| Total weight | MS01: 20kg/44 lbs MA01: 18.9kg/ 42lbs | MA012: 11.5kg/25 lbs MS019: 18.7kg/ 41 lbs | Different See Note 1 |
| Weight Capacity | 136kg/300lbs | 115 kg/250lbs | Different See Note 1 |
| Seat depth | 420 mm | MA012: 390mm MS019: 420mm | Different See Note 2 |
| Seat width | 450 mm | MA012: 420mm MS019: 450mm | Different See Note 2 |
| Seat surface height at front edge | 510mm | MA012: 520mm MS019: 596mm | Different See Note 2 |
| Frame type | Foldable | Foldable | Same |
510(k) Summary - K261075
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Traditional 510(k) Submission of Manual Wheelchair
| Frame material | Model MA01: Aluminum Model MS01: Steel | Model MA012: Aluminum Model MS019: Steel | Same |
| --- | --- | --- | --- |
| Armrest | Flip back armrest | Flip back armrest | Same |
| Footrest | Optional/ swing away | Optional/ swing away | Same |
| Tires | Front: 200mm (8') Rear: 610mm (24') | Front: 200mm (8') Rear: 315mm (12.5') | Different See Note 2 |
| Non clinical testing | | | |
| Performance | wheelchair conforms to the ISO 7176 standards | wheelchair conforms to the ISO 7176 standards | Same |
| Flammability Testing | wheelchair conforms to the ISO 16840-10 standards | wheelchair conforms to the ISO 7176-16 standards | Different See Note 3 |
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5:2009, ISO10993-10:2021, ISO 10993-23:2021 requirements. | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10, ISO 10993-23 requirements. | Different See Note 4 |
# **Substantial equivalence Analysis:**
Note 1: The predicate device and subject device have different dimension. Both of them comply with ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space, these differences do not affect safety and effectiveness.
Note 2: Both of the subject device and the predicate device comply with ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions, these differences do not affect safety and effectiveness.
Note 3: The FDA no longer recognizes ISO 7176-16; its recognition has been superseded by ISO 16840-10, and the relevant transition period has long since ended. Both the subject device and the predicate device passed the FDA-approved ignition resistance test at that time.
Note 4: Both of the subject device and the predicate device evaluated biocompatibility according to ISO 10993 series standards. Although standard version updated, test methods for the subject device and the predicate device are same.
The subject device and predicate device are substantially equivalent in the areas of technological characteristics such as basic design, features, method of operation, general function and intended use. The subject device device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
## 7. Performance Testing Summary
**The subject device Manual Wheelchair (Model: MS01,MA01) comply with:**
# **Clinical test:**
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Traditional 510(k) Submission of Manual Wheelchair
Clinical testing is not required.
# **Non-clinical data**
# *Safety and performance*
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 16840-10:2021+A1:2024 Wheelchair seating - Part 10: Resistance
to ignition of postural support devices - Requirements and test method, heat source: heating cartridge.
# *Biocompatibility*
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation
# **8. Conclusion**
The conclusions drawn from the nonclinical tests demonstrate that the subject device Manual Wheelchair(Model:MS01,MA01) is as safe, as effective, and performs as well the legally marketed predicate device K231750.
510(k) Summary - K261075
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