(52 days)
Not Found
No
The device description clearly states it is a "mechanical wheelchair" and details its manual operation and components, with no mention of AI or ML. The performance studies focus on mechanical and biocompatibility standards.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a manual wheelchair which provides mobility for individuals with limited mobility, but it does not treat or prevent any medical condition.
No
Explanation: The device is described as a "mechanical wheelchair" that provides "mobility to persons restricted to a sitting position." Its function is to assist with movement, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, mechanical wheelchair with components like a frame, seat, wheels, and brakes, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "providing mobility to persons limited to a sitting position." This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a mechanical wheelchair with wheels, a seat, footplates, and brakes. This is a physical mobility aid.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls typically associated with IVDs
The device is a medical device, specifically a manual wheelchair, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The YJ-010B series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footplates and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
Main Components: Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, leg rest strap, footplate, brake, leg rest (only device model with "-E").
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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)
Non-clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
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 maneuvering 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 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
ISO 7176-22:2014 Wheelchairs — Part 22: Set-up procedures
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Irritation (ISO 10993-23:2021)
The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
No clinical study is included in this submission.
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
§ 890.3850 Mechanical wheelchair.
(a)
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.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo features a stylized representation of a human figure, while the FDA text is presented in a clear, sans-serif font, with the acronym in a bold, blue color.
September 15, 2023
Zhenjiang Assure Medical Equipment Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Shanghai, China
Re: K232199
Trade/Device Name: Bariatric Heavy Duty Wheelchair (YJ-010B 20"DS; YJ-010B 20"DE; YJ-010B 20"DFS; YJ-010B 20"DFE;YJ-010B 20"ADS; YJ-010B 20"ADE; YJ-010B 20"ADFS; YJ-010B 20"ADFE; YJ-010B 22"DS; YJ-010B 22"DE; YJ-010B 22"DFS;YJ-010B 22"DFE; YJ-010B 22"ADS;YJ-010B 22"ADE; YJ-010B 22"ADFS; YJ-010B 22"ADFE; YJ-010B 24"DS; YI-010B 24"DE; YJ-010B 24"DFS; YJ-010B 24"DFE; YJ-010B 24"ADS; YJ-010B 24"ADE; YJ-010B 22"ADFS; YJ-010B 24"ADFE) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved
Product Code: IOR Dated: July 25, 2023 Received: July 25, 2023
Dear Eva Li:
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. 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 located 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Tushar Bansal -S
for Heather Dean, PhD 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
2
Indications for Use
510(k) Number (if known) K232199
Device Name
Bariatric Heavy Duty Wheelchair (YJ-010B 20''DE: YJ-010B 20''DFS: YJ-010B 20''DFE:YJ-010B 20'' ADS: YJ-010B 20'' ADS: YJ-010B 20"ADE: YI-010B 20''ADFS: YI-010B 22''DS: YI-010B 22''DE: YI-010B 22''DFS:YI-010B 22''DFE: YI-010B 22''ADS;YI-010B 22''ADE; YJ-010B 22''ADFS; YJ-010B 22''ADFE; YJ-010B 24''DE; YJ-010B 24''DE; YJ-0
Indications for Use (Describe)
The YJ-010B Manual Wheelchair is to provide mobility to persons limited 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
1. Submitter
Zhenjiang Assure Medical Equipment Co., Ltd. Address: No.297, Chuqiao Road, Zhenjiang City, Jiangsu Province, China Contact Person: Mei Ying Tel: +86-13852941204 Email: shelly@assuremedical.com.cn
Submission Correspondent
Contact: Eva Li
Phone: + 86 (215) 881-7802
Email: zxfda(@sungoglobal.com
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave, Shanghai, 200122 CHN
Prepared Date: July 18th,2023
2. Device
Name of Device: Bariatric Heavy Duty Wheelchair Common Name: Manual Wheelchair
Model(s):
| YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B |
|---|---|---|---|---|---|---|---|
| 20"DS | 20"DE | 20"DFS | 20"DFE | 20"ADS | 20"ADE | 20"ADFS | 20"ADFE |
| YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B |
| 22"DS | 22"DE | 22"DFS | 22"DFE | 22"ADS | 22"ADE | 22"ADFS | 22"ADFE |
| YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B |
| 24"DS | 24"DE | 24"DFS | 24"DFE | 24"ADS | 24"ADE | 24"ADFS | 24"ADFE |
Regulatory Information
Classification Name: Mechanical Wheelchair
Regulatory Class: I
Product code: IOR
Regulation Number: 890.3850
Review Panel: Physical Medicine
3. Predicate device:
K201461 Ningbo Shenyu Medical Equipment Co.,Ltd. Manual Wheelchair (A011)
4. Device description
The YJ-010B series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a
4
sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footplates and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, leg rest strap, footplate, brake, leg rest (only device model with "-E").
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
| Model | YJ-010B series | |||
|---|---|---|---|---|
| Overall dimension | -E: 1275mm(L)1258mm(H) 20"width 730mm/22"width 780mm/24"width 830mm | |||
| -S: 1175 mm(L)*1258mm(H) 20"width 730mm/22"width 780mm/ 24"width 830mm | ||||
| Folded dimension | Width 310mm | |||
| Seat width | 20" 509mm | Backrest width | 20" 497mm | |
| 22" 559mm | 22" 547mm | |||
| 24" 610mm | 24" 597mm | |||
| Seat depth | 485mm | Seat height from floor | 547mm | |
| Backrest angle | 10° | Backrest height | 420mm | |
| Footplate length | -E: 245 mm | |||
| -S:370 mm | Footplate-to-seat distance | -E: 448-555mm | ||
| -S:370-520mm | ||||
| Footplate clearance | 50mm | Footplate-leg-angle | 95° | |
| Front location of armrest structure | -D: 275mm | |||
| -F: 432mm | Front-armrest-to-backrest distance | -D: 275mm | ||
| -F: 432mm | ||||
| Front-armrest-to-backrest distance | -D: 275mm | |||
| -F: 432mm | Armrest length | -D: 260mm | ||
| -F: 352mm | ||||
| Leg-to-seat-surface angle | 110° | Armrest angle | 25° | |
| Material | Q235 | Armrest-to-seat distance | 245mm | |
| Distance between armrests | 20" 510mm | |||
| 22" 560mm | ||||
| 24" 610mm | Seat plane angle | 3° | ||
| Hand rim diameter | Φ 570mm | Armrest width | 55mm | |
| Maximum weight bearing | 500LBS |
The specification table is as below:
5
| capacity of the device | ||||
|---|---|---|---|---|
| Horizontal location of axle | 65° | Weight of the device(net) | 20" | 27.3kg |
| 22" | 27.5kg | |||
| 24" | 27.7kg | |||
| diameter of front wheels | Φ190mm | diameter of rear wheels | Φ613mm | |
| Backpack carrier or permission | N/A | Static stability sideways | 11.75° | |
| Static stability uphill | 12.8° | Static stability downhill | 13.2° | |
| Minimum turning radius | 865mm | |||
| Parking brake | ||||
| Max slope uphill | 7.3° | |||
| Max slope downhill | 7.1° |
5. Indication for use
The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.
| Device | Predicate Device | Proposed Device | Results |
|---|---|---|---|
| 510(k) Number | K201461 | K232199 | -- |
| Manufacturer | Ningbo Shenyu Medical Equipment | ||
| Co., Ltd. | Zhenjiang Assure Medical | ||
| Equipment Co., Ltd. | -- | ||
| Proprietary Name | Manual Wheelchair | Bariatric Heavy Duty Wheelchair | -- |
| Classification | I | I | same |
| Indications for use | The A011 Manual wheelchair is to | ||
| provide mobility to persons limited | |||
| to a sitting position. | The YJ-010B Manual Wheelchair is | ||
| to provide mobility to persons | |||
| limited to a sitting position. | same | ||
| Design | |||
| Characteristic | Manual Operation, Four-Wheels, | ||
| Foldable, Cross-Brace, Pull-to-Lock, | |||
| Armrest, Backrest, Foot rest | Manual Operation, Four-Wheels, | ||
| Foldable, Cross-Brace, Pull-to- | |||
| Lock, Armrest, Backrest, Foot rest, | |||
| side panel | Similar*1 | ||
| Brake control | occupant-operated brake only | occupant-operated brake only | same |
| Operation | |||
| Environment | For indoor/outdoor use | For indoor/outdoor use | same |
| Control Mode | Mechanical | Mechanical | same |
| Size(unfold) | 1100 (L) *660 (W) * 910mm (H) | -E: 1275mm(L)1258mm(H) | |
| 20"width 730mm/22"width | |||
| 780mm/24"width 830mm | |||
| -S: 1175 mm(L)*1258mm(H) | Different*2 |
6. Comparison of technological characteristics with the predicate device
6
| | | 20"width 730mm/22"width
780mm/ 24"width 830mm | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Stowage
length/width/height | 810 (L) X 320 (W) X 930mm (H) | E: 1275mm(L)1258mm(H)310m(W)
S: 1175 mm(L)1258mm(H)310mm(W) | different2 |
| Weight (Total) | 16kg(35.2lbs) | 27.3-27.7Kg | different2 |
| Weight Capacity | 136Kg(300lbs) | 500LBS | different2 |
| Seat Width | 480mm | 509-610mm | different2 |
| Seat height | 540mm | 547mm | different2 |
| Seat depth | 420mm | 485mm | different2 |
| Back type | Fixed | Fixed | Same |
| Tires | Front: 200mm
Rear:610mm | Front: 190mm
Rear:613mm | different2 |
| Armrest | Flip back armrest | Armrest height adjustable (-A)/fixed | Similar3 |
| Foot rest | Optional/ swing away Optional/
swing away | with elevating leg rest(-E)
with swing-away leg rest(-S) | Similar3 |
| Rear Axle Position | Single | Single | Same |
| Frame | Foldable frame | Foldable frame | Same |
| Construction | Push inward from left and right
sides to fold | Push inward from left and right
sides to fold | Same |
| Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same |
| Performance | Comply with:
ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16 | Comply with:
ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16 | Same |
| Biocompatibility | Comply with:
ISO10993-1
ISO10993-5
ISO10993-10 | Comply with:
ISO10993-5
ISO10993-10
ISO10993-23 | Similar4 |
Discussion :
| Similar*1: | Compared to the predicate device, the subject device adds two skirt guards which |
|---|---|
| are installed to the sides of the seat frame under the arm rests to provide a barrier | |
| between the occupant and the wheels. This feature can prevent occupant's clothes | |
| from getting caught in the wheels. This feature will not raise any new risk | |
| of safety or effectiveness. |
7
| Different2: | Compared to the predicate device, the subject device has different value on the
unfold size, stowage size, device weight, capacity, seat width, seat height, seat
depth, and tire size. However, the subject has passed the and , so the above
different will not raise any new risk of safety or effectiveness. |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similar3: | Compared to the predicate device, the subject device model with "-E" adds the
elevating leg rest. This component provides convenience for orthopedic surgery
patients and the armrest of the subject can't be flipped. The above differences will
not raise any new risk of safety or effectiveness. |
| Similar*4: | The stimulation test in ISO 10993-23 replaces the stimulation test in ISO 10993-
10:2010. It will not raise any new risk of safety or effectiveness. |
7. Summary of Non-Clinic Performance Testing
Performance Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
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 maneuvering 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 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices ISO 7176-22:2014 Wheelchairs — Part 22: Set-up procedures
Biocompatibility
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included:
- · Cytotoxicity (ISO 10993-5:2009)
- · Sensitization (ISO 10993-10:2010)
- Irritation (ISO 10993-23:2021)
The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
8. Clinical Test Conclusion
No clinical study is included in this submission.
8
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission is as safe and effective as the legally marketed predicate device cleared under K201461.