(61 days)
Not Found
No
The device description clearly states it is a "mechanical wheelchair" that is "manually operated, attendant propelled" and "controlled, steered and operated completely by a trained caregiver." There is no mention of any automated or intelligent features.
No
The device provides mobility support for persons limited to a sitting position, which is a supportive function rather than an active therapeutic treatment or intervention.
No
The device is a wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly states it is a mechanical wheelchair with a frame, seat, footrests, and wheels, indicating it is a hardware device.
Based on the provided text, 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, tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MA012 and MS019 wheelchairs are "mechanical wheelchairs" and "manually operated, attendant propelled transport devices." Their purpose is to provide mobility to individuals.
- Intended Use: The intended use is to "provide mobility to persons limited to a sitting position." This is a physical function, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
The device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
MA012 Aluminum wheelchair and MS019 Steel wheelchair are mechanical wheelchairs which is a manually operated, attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. The wheelchair is controlled, steered and operated completely by a trained caregiver.
The wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. There are two models of the wheelchair, MA012 and MS019. The MA012 Aluminum wheelchair has an aluminum frame, fixed armrest and a foldable back, while the MS019 Steel wheelchair has a steel frame, fixed back and a detachable, flip-back armrest. The wheelchair can support users of up to115 kg.
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
manually operated, attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
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 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 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- 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 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 strength
- 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 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
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 shows 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.
August 15, 2023
Sichuan AST Medical Equipment Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K231750
Trade/Device Name: MA012 Aluminum wheelchair, MS019 steel wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: June 15, 2023 Received: June 15, 2023
Dear Ivy Wang:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE 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.
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
Enclosure
2
Indications for Use
510(k) Number (if known) K231750
Device Name
MA012 Aluminum wheelchair, MS019 steel wheelchair
Indications for Use (Describe)
MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose 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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3
510(k) Summary
K231750
l. Applicant
Name: Sichuan AST Medical Equipment Co., Ltd.
Address: No.58 JinPeng Road, Area C, West Industrial Park, Luxian County, Luzhou, Sichuan,
646100 CN
Name of contact person: Ms. Mae Tse
Telephone: +86 830 8130333
Email: sales01@ast168.cn
Date prepared: 2023-08-11
II. Submission Correspondent
Ms. Ivy Wang
Shanghai SUNGO Management Consulting Co., Ltd.
Tel: +86-21-5881 7802
Email: zxfdaf@sungoglobal.com
III. Device
Device trade name: MA012 Aluminum wheelchair, MS019 Steel wheelchair
Common name: Manual Wheelchair
Regulatory Information:
Classification name: Mechanical Wheelchair
Regulation class: 1
Regulation number: 21CFR 890.3850
Panel: Physical Medicine
Product code: IOR
IV. Predicate device
Primary - K181795
AST Model MA012 and MS019 Rehab Wheelchair
Sichuan AST Medical Equipment Co., Ltd
4
V. Device description
MA012 Aluminum wheelchair and MS019 Steel wheelchair are mechanical wheelchairs which is a manually operated, attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. The wheelchair is controlled, steered and operated completely by a trained caregiver.
The wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. There are two models of the wheelchair, MA012 and MS019. The MA012 Aluminum wheelchair has an aluminum frame, fixed armrest and a foldable back, while the MS019 Steel wheelchair has a steel frame, fixed back and a detachable, flip-back armrest. The wheelchair can support users of up to115 kg.
VI. Indication for use
MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position.
VII. Non-Clinical Test Conclusion
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 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- . 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 dimensions, mass and
5
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 strength
- . 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 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
VIII. Comparison with the predicate device
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Manufacturer | Sichuan AST Medical | ||
| Equipment Co., Ltd. | Sichuan AST Medical Equipment | ||
| Co., Ltd. | / | ||
| Proprietary name, | |||
| model | MA012 Aluminum wheelchair, | ||
| MS019 Steel wheelchair | AST Model MA012 and MS019 | ||
| Rehab Wheelchair | / | ||
| 510(k) number | K231750 | K181795 | / |
| Device classification | |||
| name | Class I | Class I | Same |
| Classification | |||
| regulations | 21 CFR 890. 3850 | 21 CFR 890. 3850 | Same |
| Product code | IOR | IOR | Same |
| Indication for use | MA012 Aluminum wheelchair | ||
| and MS019 steel wheelchair | |||
| are intended for medical | |||
| purpose to provide mobility to | |||
| persons limited to a sitting | |||
| position. | The AST Model MA012 and | ||
| MS019 Rehab Wheelchairs are | |||
| to provide mobility to persons | |||
| limited to a sitting position. | Same | ||
| Dimension (Length x | |||
| Width x Height) | Model MA012: | ||
| 950x610x970mm | |||
| Model MS019: | |||
| 916x574x896mm | Model MA012: | ||
| 1173x645x892mm (±1mm) | |||
| Model MS019: | |||
| 1196x775x894mm (±1mm) | Similar | ||
| The two physical | |||
| dimensions are | |||
| different. The | |||
| difference does | |||
| Attribute | Subject device | Predicate device | Results |
| Total weight | Model MA012: 11.5kg/25 lbs | ||
| Model MS019: 18.7kg/41 lbs | Model MA012: 17.2kg/38 lbs | ||
| Model MS019: 20kg/ 46 lbs | not affect | ||
| effectiveness and | |||
| safety. | |||
| Similar | |||
| Different weight of | |||
| the device do not | |||
| raise the safety | |||
| and effectiveness | |||
| of the device. | |||
| Weight Capacity | 115 kg/250lbs | Model MS019: 200 kg/450 lbs, | |
| Model MA012: 136kg/ 300 lbs | Similar | ||
| Difference on | |||
| loading weight will | |||
| not cause | |||
| different | |||
| performance. | |||
| Lower weight | |||
| provide less | |||
| pressure to the | |||
| chair and easy for | |||
| the transportation. | |||
| Seat depth | Model MA012: 390mm | ||
| Model MS019: 420mm | Model MA012: | ||
| 16"-20" (406mm-508mm) | |||
| Model MS019: | |||
| 18"-20" (457mm-508mm) | Similar | ||
| Different seat size | |||
| do not raise the | |||
| safety and | |||
| Seat width | Model MA012: 420mm | ||
| Model MS019: 450mm | Model MA012: 16" (406mm); 18" | ||
| (457mm); 20" (508mm) | |||
| Model MS019: 18" (457mm); | |||
| 20" (508mm); 22" (558mm); 24" | |||
| (609mm) | effectiveness of | ||
| the device. | |||
| Seat height | Model MA012: 520mm | ||
| Model MS019: 596mm | Model MA012: 19.7" (500mm) | ||
| Model MS019: 19.8" (503mm) | |||
| Frame type | Foldable | Foldable | Same |
| Frame material | Model MA012: Aluminum | ||
| Model MS019: Steel | Model MA012: Aluminum | ||
| Model MS019: Steel | Same | ||
| Back style | Model MS019: Fixed | ||
| Model MA012: foldable | Model MS019: Fixed | ||
| Model MA012: Adjustable | Similar | ||
| The slight | |||
| difference on back | |||
| style do not raise | |||
| the safety and | |||
| effectiveness of | |||
| the device. | |||
| Armrest | Flip back armrest | Model MA012: Height Adjustable | |
| desk length armrest. Flip back | Similar | ||
| The height of | |||
| Attribute | Subject device | Predicate device | Results |
| Model MS019: Fixed or adjustable height; desk or full length; removable | armrest of proposed device can not be adjustable. | ||
| Footrest | Optional/ swing away | Optional/ swing away | Same |
| Rear Axle Position | Single | Multiple | Similar |
| The rear axle of proposed device has only one size. | |||
| Tires | Front: 200mm (8") | ||
| Rear: 315mm (12.5") | Front: 6",7",8" | ||
| Rear: 20",22",24" | Similar | ||
| Minor difference on dimension of driven wheel will not cause different performance. |
Table 1 General Comparison
6
7
Substantial equivalence Analysis:
The design and technological characteristics of the subject device is basically similar to the predicate device chosen. There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.
Therefore, the subject device is substantially equivalent to the predicate device.
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5, | |||
| ISO10993-10, ISO 10993-23 | |||
| requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and | |||
| ISO10993-10 requirements. | S.E. | ||
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
Table 2 Safety comparison
Table 3 Safety comparison
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| ISO7176-1 | The Static stability has been | ||
| determined after the testing | |||
| according to the ISO 7176-1, and | |||
| test results meet its design | |||
| specification. | The Static stability has been | ||
| determined after the testing | |||
| according to the ISO 7176-1, | |||
| and test results meet its design | |||
| specification. | S.E. | ||
| Attribute | Subject device | Predicate device | Results |
| ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5. | The dimensions, mass has been determined after the testing according to the ISO 7176-5. | S.E. |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | S.E. |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | S.E. |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11. | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11. | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | S.E. |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | S.E. |
| ISO 7176-16 | The performance of resistance to ignition meets the requirements of ISO 7176-16 | The performance of resistance to ignition meets the requirements of ISO 7176-16. | S.E. |
8
IX. Summary of clinical testing
No clinical study is included in this submission.
Conclusions X.
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well the legally marketed predicate device K181795.