(353 days)
Not Found
No
The description details a purely mechanical wheelchair with no mention of software, sensors, or any computational elements that would suggest AI/ML.
No
A mechanical wheelchair, like the A011, provides mobility assistance rather than directly treating or curing a medical condition, which is the primary function of a therapeutic device. It helps manage the effects of an existing condition but doesn't offer therapy itself.
No
The device is described as a mechanical wheelchair, which provides mobility and replaces walking. It does not mention any function related to diagnosing a disease, condition, or state of being.
No
The device description clearly outlines a physical, mechanical wheelchair with components like a frame, wheels, and upholstery, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text clearly describes a manual wheelchair, which is a mechanical device used for mobility. It does not involve any testing of biological samples.
- Intended Use: The intended use is "to provide mobility to persons limited to a sitting position," which is a physical function, not a diagnostic one.
- Lack of IVD Indicators: The description lacks any mention of reagents, assays, sample collection, analysis of biological materials, or any other elements typically associated with IVD devices.
Therefore, based on the provided information, the A011 Manual Wheelchair is a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The A011 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
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.
Main Components: Main frame, back upholstery, seat upholstery, handgrip, arm pad, armrest, front wheel, handrim, antitipper, crossbrace, crossbar, side panel, Legrest strap, footplate, Seat belt, brake.
Main materials: Frame, crossbrace, crossbar, armrest, brake: Aluminum, yellow/black coating Handgrip, side panel, handrim, footplate: PVC Seat and back upholstery: Cover is Nylon fabrics, inside with flame resistant foam Armrest pad: flame retardant sponge &PU
The device can be operated indoors 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 Test: Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-1 :2018, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 7176-1:2014, ISO 7176-3: 2012, ISO 7176-5, Second edition 2008-06-01, ISO 7176-7. First Edition 1998-05-15, ISO 7176-8:2014, ISO 7176-11:2012, ISO 7176-13, First edition 1989-08-01, ISO 7176-15:1996, ISO 7176-16: 2012. Tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989. The tests indicated that the proposed device performs comparably to the predicate device, meeting all relevant requirements for static stability, brake effectiveness, dimensions, seating and wheel dimensions, static/impact/fatigue strengths, information disclosure/documentation/labeling, and resistance to ignition. Biocompatibility tests for cytotoxicity, irritation, and sensitization also showed compliance.
Animal Study: No clinical study is included in this submission.
Clinical Study: 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 21, 2021
Ningbo Shenyu Medical Equipment Co., Ltd. % Vivi Shi Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, Shanghai 200122 China
Re: K201461
Trade/Device Name: Manual Wheelchair, Model A011 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: March 1, 2021 Received: March 5, 2021
Dear Vivi Shi:
We have reviewed vour 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 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
1
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 mediation-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,
Heather Dean, PhD Assistant Director. Acute Injurv 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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Indications for Use
510(k) Number (if known) K201461
Device Name Manual Wheelchair, Model A011
Indications for Use (Describe)
The A011 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)
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510(K) Summary - K201461
I. Submitter
Ningbo Shenyu Medical Equipment Co.,Ltd.
Address: No.1318 West of Tanjialing Road, Yuyao, Zhejiang, China
Contact Person: Zhou Yuefeng Tel: +86- 574-62517777 Email: sales@shenyumedical.com
Submission Correspondent: Primary contact: Mrs. Vivi Shi Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: wei.shi@sungoglobal.com Secondary contact: Mr. RaymondLuo Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda .sungo@gmail.com
II. Device
Name of Device: Manual Wheelchair Common Name: Manual Wheelchair Model(s): A011
Regulatory Information Classification Name: Mechanical Wheelchair Regulatory Class: I Product code: IOR Regulation Number: 890.3850 Review Panel: Physical Medicine
III. Predicate device:
Sichuan AST MedicalEquipment Co., Ltd. AST Model MA012 and MS019 Rehab Wheelchair 510Knumber: K181795
This predicate has not been subject to a design-related recall.
IV. Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
4
Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, arm pad, armrest, front wheel, handrim, antitipper, crossbrace, crossbar, side panel, Legrest strap, footplate, Seat belt, brake.
- Main materials:
Frame, crossbrace, crossbar, armrest, brake: Aluminum, yellow/black coating
Handgrip, side panel, handrim, footplate: PVC
Seat and back upholstery: Cover is Nylon fabrics, inside with flame resistant foam
Armrest pad: flame retardant sponge &PU
The device can be operated indoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The specification table is as below:
| Main dimensions and structural parameters | |||
|---|---|---|---|
| Overall dimension | 1100mm (L) X 660mm (W) X 910mm (H) | ||
| Folded dimension | 810mm (L) X 320mm (W) X 930mm (H) | ||
| Seat width | 475mm | Horizontal angle of seat | 8° |
| Seat depth | 420 mm | Backrest angle | 14° |
| Seat height from floor | 510mm | Angle of the legrest against the seat surface | 65° |
| Distance between armrest and seat | 180 mm | Distance from footrest to seat | 410mm |
| Distance between armrests | 500 mm | Front position of armrest structure | 370mm |
| Backrest height | 370 mm | Diameter of armrest circle on rear wheels | 530mm |
| Footrest height from floor | 145mm | Horizontal position of shaft | 2.5mm |
| Weight of the heaviest part | |||
| (net weight) | 13.5 Kg | ||
| Load capacity | 136Kg (300LB) | ||
| Specification of front wheels | Ø200mm | ||
| Specification of rear wheels | Ø600 mm | ||
| Main technical performance | |||
| Wheel landing performance | All wheels except the lifting wheels must land smoothly | ||
| Static stability | Vertical forward tilt ≥10°, vertical backward tilt≥10°, and lateral tilt ≥15° | ||
| Hill-holding performance | >8° | ||
| Sliding offset | ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In VitroCytotoxicity |
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin > Sensitization
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ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
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ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
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ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
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ISO 7176-7. First Edition 1998-05-15, Wheelchairs - Part 7: Measurement of seating and wheeldimensions
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ISO 7176-8:2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatiguestrengths
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ISO 7176-11:2012 Test dummies
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ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of test surfaces
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ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
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ISO 7176-16: 2012 Resistance to ignition of postural support devices
Substantial Equivalence discussion:
Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device.
The following table (Table 2&3) shows similarities and differences of the performance between our device and the predicate device. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for "Manual Wheelchair A011" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device.
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| Description | Proposed Device | Predicate device |
|---|---|---|
| Static stability | Meets ISO 7176-1:2014 | Meets ISO 7176-1:2014 |
| Effectiveness of brakes | Meets ISO 7176-3:2012 | Meets ISO 7176-3:2012 |
| Dimensions, mass and maneuvering space | Meets ISO 7176-5:2008 | Meets ISO 7176-5:2008 |
| Seating and wheel dimensions | Meets ISO 7176-7:1998 | Meets ISO 7176-7:1998 |
| Static, impact, and fatigue strengths | Meets ISO 7176-8:2014 | Meets ISO 7176-8:2014 |
| Information disclosure, documentation and | ||
| labeling | Meets ISO 7176-15:1996 | Meets ISO 7176-15:1996 |
| Resistance to ignition | Meets ISO 7176-16:2012 | Meets ISO 7176-16:2012 |
Table 2 Performance comparison
Table 3 Biocompatibility Comparison
| Item | Proposed device | Predicate device | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, not cytotoxicity effect. | Comply with ISO 10993-5 | Same |
| Irritation | Under the conditions of the study, not an irritant. | Comply with ISO 10993-10 | Same |
| Sensitization | Under the conditions of the study, not a sensitizer. | Comply with ISO 10993-10 | Same |
Difference analysis:
The tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989.
A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Proposed Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:
Manual wheelchair is safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use.
A brief discussion of the clinical submitted, reference, or relied on in the premarket notification for a determination of substantialequivalence.
According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.
Animal Study
No clinical study is included in this submission.
Clinical Study
No clinical study is included in this submission.
VIII. Conclusion
Based on the comparison of the proposed device of A011 is determined to be Substantially Equivalent (SE) to the predicate device of AST Model MA012 and MS019 Rehab Wheelchair, in respect of safety and effectiveness.