(289 days)
Not Found
No
The device description and performance studies indicate a purely mechanical wheelchair with no mention of AI or ML components or functionality.
No.
The device is a manual wheelchair, which provides mobility, not therapy.
No
Explanation: The device is a manual wheelchair, which provides mobility. It does not perform any diagnostic functions like analyzing data or detecting medical conditions.
No
The device description explicitly lists physical components like a main frame, seat, wheels, footrests, and brakes, and the performance studies refer to testing of physical properties like stability, brake effectiveness, and strength, all indicating a hardware device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Manual Wheelchair Function: The description clearly states the manual wheelchair's intended use is to "provide mobility to persons limited to a sitting position." It is a mechanical device for physical support and movement.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide any diagnostic information about a patient's health status.
- Performance Studies: The performance studies listed focus on the physical characteristics and safety of the wheelchair (stability, brakes, dimensions, strength, biocompatibility), not on the accuracy or reliability of diagnostic test results.
The manual wheelchair is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 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 S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre 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, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt.
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 as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- A 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 A space
- ISO 7176-7: 1998 Wheelchairs Part 7: Measurement of seating and wheel dimensions ISO A 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 V
- ISO 7176-13: 1989 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces V
-
ISO 7176-15: 1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 16840-10:2021 Wheelchair seating- Part 10: Resistance to ignition of postural support devices > Requirements and test method
- ISO 7176-22:2014 Wheelchairs Part 22: Set-up procedures >
Biocompatibility testing was conducted in accordance with the 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)
- ﺮ Sensitization (ISO 10993-10:2021)
-
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.
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 parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a square.
February 28, 2025
Anhui JBH Medical Apparatus Co., Ltd % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai China
Re: K241374
Trade/Device Name: Manual Wheelchair (Models: S002, S004, S005, S006, S007, S008, S009) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: February 26, 2025 Received: February 26, 2025
Dear Jarvis Wu:
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"
1
(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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 Rue"). 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-advicecomprehensive-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-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).
2
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
3
Indications for Use
510(k) Number (if known) K241374
Device Name
Manual Wheelchair (Models: S002, S004, S005, S006, S007, S008, S009)
Indications for Use (Describe)
The 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."
4
510(K) Summary
Document Prepared Date: 2025/2/28
A. Applicant:
Name: Anhui JBH Medical Apparatus Co., Ltd Address: No.116 QiCang Road Industrial District MingGuang Chuzhou,Anhui, China
Contact Person: Wei yuan wei Tel: +86- 0550-8108866 Email: outreach@jbhmedical.com
Submission Correspondent: Primary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com
Secondary contact: Mr. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda(@sungoglobal.com
B. Device:
Trade Name: Manual Wheelchair (Models: S002, S004, S005, S006, S007, S008, S009) Common Name: Manual Wheelchair Models: S002, S004, S005, S006, S007, S008, S009
Regulatory Information
Classification Name: Wheelchair, Mechanical Classification: Class I Product code: IOR Regulation Number: 21 CFR 890.3850
Review Panel: Physical Medicine
C. Predicate device: K232230 YJ-K1/K2 Wheelchair Zhenjiang Assure Medical Equipment Co., Ltd
5
D. Device Description:
The S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre 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, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
E. Indications for Use:
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
F. Comparison of Technological Characteristics with the Predicate Device Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| 510K Number | K241374 | K232230 | --- |
| Manufacturer | Anhui JBH Medical Apparatus | ||
| Co., Ltd | Zhenjiang Assure Medical | ||
| Equipment Co., Ltd. | --- | ||
| Proprietary Name | Manual Wheelchair | YJ-K1/K2 Wheelchair | --- |
| Model | S002, S004, S005, S006, S007, | ||
| S008, S009 (7 models) | 24 models | --- | |
| Classification | I | I | Same |
| Indications for use | The Manual Wheelchair is | ||
| intended for medical purposes | |||
| to provide mobility to persons | |||
| restricted to a sitting position. | The YJ-K1/K2 Manual | ||
| Wheelchair is to provide | |||
| mobility to persons limited to | |||
| a sitting position. | Same | ||
| Design | |||
| Characteristic | Manual Operation, Four- | ||
| Wheels, Foldable, Cross- | |||
| Brace, Quick release hub,Seat | |||
| cushion ,Backrest, Footrests, | |||
| Protective cover, Anti-tipper, | |||
| brake. | Manual Operation, Four- | ||
| Wheels, Foldable, Cross- | |||
| Brace, Pull-to- Lock, Armrest, | |||
| Backrest, Foot rest, skirt | |||
| guard , Anti-tipper (selected | |||
| models), brake extender | |||
| (selected models) | Similar | ||
| Brake control | occupant-operated brake only | occupant-operated brake only | Same |
| Operation | For indoor/outdoor use | For indoor/outdoor use | Same |
| Environment | |||
| Control Mode | Mechanical | Mechanical | Same |
| Size(unfold) | S002: 815610765mm | ||
| S004:810595810mm | |||
| S005:810595790mm | |||
| S006:815570765mm | |||
| S007:815590765mm | |||
| S008:815630765mm | |||
| S009:815650765mm | 1220 (L) *660/640/700 (W) * | ||
| 857/908mm (H) | Analysis #1 | ||
| Stowage | |||
| length/width/height | S002: 815350765mm | ||
| S004: 810595650mm | |||
| S005: 810595620mm | |||
| S006: 815350765mm | |||
| S007: 815350765mm | |||
| S008: 815350765mm | |||
| S009: 815350765mm | 1220(L)*280/285/310(W)*857/ | ||
| 90 8mm(H) | Analysis #1 | ||
| Weight(Total) | 12.5kg/14.0kg/14.5kg | 20.0kg/22.6kg | Analysis #1 |
| Weight Capacity | 100kg | 136Kg(300lbs) | Analysis #1 |
| Seat Width | 380mm | 405/455/505mm | Analysis #1 |
| Seat height | 510/520mm | 490mm/445mm | Analysis #1 |
| Seat depth | 430mm | 16",18",20" | Analysis #1 |
| Back type | Fixed | Fixed | Same |
| Tires | Front: 105mm | ||
| Rear:595mm | Front: 193mm | ||
| Rear:610mm | Analysis #1 | ||
| Foot rest | swing away footrest/ elevating | ||
| leg rest | swing away footrest/ elevating | ||
| leg rest | Same | ||
| Rear Axle Position | Single | Single | Same |
| Frame | |||
| Construction | Foldable frame Push inward | ||
| from left and right sides to fold | Foldable frame Push inward | ||
| from left and right sides to fold | Same | ||
| Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same |
| Maximum Safe | |||
| Operational | |||
| incline | Vertical forward tilt ≥8°, | ||
| vertical backward tilt ≥8°, | |||
| and lateral tilt ≥8° | Vertical forward tilt ≥10°, | ||
| vertical backward tilt ≥10°, | |||
| and lateral tilt ≥10° | Analysis #2 | ||
| braking time | The manual wheelchair brake | ||
| is mechanical structure and | |||
| manual braking, and the | |||
| braking time can be ignored | |||
| when it is used immediately. | The manual wheelchair | ||
| brake is mechanical structure | |||
| and manual braking, and the | |||
| braking time can be ignored | |||
| when it is used immediately. | Same | ||
| braking distance | brake is mechanical structure | ||
| and manual braking, and the | |||
| braking distance can be | |||
| ignored. | brake is mechanical structure | ||
| and manual braking, and the | |||
| braking distance can be | |||
| ignored. | Same | ||
| Performance | Comply with: | ||
| ISO7176-1 | |||
| ISO7176-3 | |||
| ISO7176-5 | |||
| ISO7176-7 | |||
| ISO7176-8 | |||
| ISO7176-11 | |||
| ISO7176-13 | |||
| ISO7176-15 | |||
| ISO 16840-10 | 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 | |||
| ISO10993-23 | Comply with: | ||
| ISO10993-1 | |||
| ISO10993-5 | |||
| ISO10993-10 | Same |
6
7
Difference Analysis:
-
- Compare the predicate device, the subject device have different value on the unfold size, stowage size, device weight, Capacity, Seat Width, Seat height, Seat depth, Tires size. However the subject has pass the and , so the above different will not raise any new risk of safety or effectiveness.
-
- The Safe Operational incline is not identical, the subject device has passed the bench performance testing. So it will not raise any new risk of safety or effectiveness.
G. Summary of Non-Clinic Performance Testing
Performance Testing
Non-clinical tests were conducted to verify that the subject 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:
- A ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- A 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 A space
- ISO 7176-7: 1998 Wheelchairs Part 7: Measurement of seating and wheel dimensions ISO A 7176-8: 2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
8
No.116 QiCang Road Industrial District MingGuang Chuzhou,Anhui, China
- ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies V
- ISO 7176-13: 1989 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces V
-
ISO 7176-15: 1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 16840-10:2021 Wheelchair seating- Part 10: Resistance to ignition of postural support devices > Requirements and test method
- ISO 7176-22:2014 Wheelchairs Part 22: Set-up procedures >
Biocompatibility
Biocompatibility testing was conducted in accordance with the 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)
- ﺮ Sensitization (ISO 10993-10:2021)
-
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.
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Manual Wheelchair is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K232230.