(333 days)
No
The device description details a traditional, manually operated mechanical wheelchair with no mention of any software, computational components, or AI/ML related terms.
No
The device is a manual wheelchair, which provides mobility, but it does not directly treat or prevent a disease or condition; therefore, it is not considered a therapeutic device.
No
The device's intended use is to provide mobility, not to diagnose a medical condition.
No
The device description clearly outlines a physical, mechanical wheelchair made of materials like magnesium alloy and stainless steel, with components like wheels, frame, footplates, and brakes. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons restricted 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, which is a mobility aid. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, the Manual Wheelchair model XSG106A is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes
IOR
Device Description
The proposed device, Manual Wheelchair model XSG106A, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.
The main frame is made of magnesium alloy frame, the materials meet the standard of ASTM B107M-2012, and which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base.
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
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 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 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 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support device.
ISO 7176-22:2014 Wheelchairs - Part 15: Set-Up Procedure
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
March 1, 2019
Jiangyin Newrise Medical Equipment Co., Ltd % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn
Re: K180852
Trade/Device Name: Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 2, 2019 Received: January 7, 2019
Dear Ray 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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180852
Device Name
Manual Wheelchiar
Indications for Use (Describe)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
× 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 Druq 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."
t
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
EF
PSC Publishing Services (301) 443-6740
3
Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K180852
-
- Date of Preparation
02/27/2019
- Date of Preparation
-
Sponsor 2.
JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD.
No.97, WenXin Road, LinGang Street, JiangYin City, JiangSu Province,China 214400 Establishment Registration Number: Not yet registered or the Number Contact Person: Huang Bing Position: General Manager Tel: +86-510-86092581 Fax: +86-510-89062698 Email: Top.Brian@inewrise.cn
-
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Manual Wheelchair Common Name: Mechanical Wheelchair Model(s): XSG106A
Regulatory Information: Classification Name: Wheelchair, Mechanical Classification: I; Product Code: IOR; Regulation Number: 21 CFR 890.3850; Review Panel: Physical Medicine;
Intended Use Statement:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description 5.
The proposed device, Manual Wheelchair model XSG106A, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.
The main frame is made of magnesium alloy frame, the materials meet the standard of ASTM B107M-2012, and which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base.
5
6. Identification of Predicate Device
Predicate # 510(k) Number: K163352 Product Name: Wheelchair Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.
Non-Clinical Test Conclusion 7.
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 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 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 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support device.
ISO 7176-22:2014 Wheelchairs - Part 15: Set-Up Procedure
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.
-
- Clinical Test Conclusion
No Clinical Test conducted.
- Clinical Test Conclusion
6
9. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| ITEM | Predicate Device (K163352) | Proposed Device | Remark |
|---|---|---|---|
| Product Code | IOR | IOR | SE |
| Regulation No. | 21 CFR 890.3850 | 21 CFR 890.3850 | SE |
| Class | 1 | 1 | SE |
| Intended Use | The device is intended for medical | ||
| purposes to provide mobility to persons | |||
| restricted to a sitting position. | The device is intended for medical | ||
| purposes to provide mobility to persons | |||
| restricted to a sitting position. | SE | ||
| Design | |||
| Characteristic | Manual Operation, Four-Wheels, | ||
| Foldable, Cross-Brace, Pull/Push-to-Lock, | |||
| Armrest, Backrest, Footpad | Manual Operation, Four-Wheels, | ||
| Foldable, Cross-Brace, Pull-to-Lock, | |||
| Armrest, Backrest, Footpad | SE | ||
| Operation | |||
| Environment | For Indoor/Outdoor use | For Indoor/Outdoor use | SE |
Table 2 Performance Comparison
| ITEM | Predicate Device (K163352) | Proposed Device | Remark |
|---|---|---|---|
| Overall | |||
| Dimensions | Length: 1137 mm (44.8") | Length: 1030 mm | Analysis |
| Width: 680 mm (26.8") | Width: 640 mm | ||
| Height: 880 mm (34.6") | Height: 930 mm | ||
| Rear Wheel | Size: 559 mm (22") | Size: 610 mm | Analysis |
| Tire Type: Rubber | Tire Type: PU Solid Material | ||
| Rim Diameter/Material: 510.7 mm | |||
| (20.1")/Steel Composite | Rim Diameter/Material: 534 mm/Steel | ||
| Composite | |||
| Wheel Lock | Pull-to-Lock, Push-to-Lock | Pull-to-Lock | SE |
| Ground Clearance | 64 mm (2.5") | 150 mm | Analysis |
| Min. Turning | |||
| Diameter | 1915.2 mm (75.4") | 1700 mm | Analysis |
| Armrest | Arm pad: Paded | ||
| Height-Adjustable: No | Height-Adjustable: No | SE | |
| Seat Dimensions | Depth: 420 mm (16.5") | Depth: 460 mm | Analysis |
| Height: 470 mm (18.5") | Height: 420 mm | ||
| Width: 410 mm (16.1") | Width: 410 mm | ||
| Casters | Size: 152 mm (6") | Size: 200 mm | Analysis |
| Tire Type: PU | Tire Type: PVC Solid Material | ||
| Weight of | |||
| wheelchair | 11.07kg | 18kg | Analysis |
| Weight Capabity | 100kg |
Difference Analysis:
- a. Overall Dimensions, the proposed device has minor different overall dimensions with predicate device, this specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design
7
specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
- Rear Wheel, the proposed device has different rear wheel size and materials with predicate device, b. this specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
- Ground Clearance, the proposed device has more ground clearance than predicate device, which is C. meet the design specification and has better trafficability characteristic than predicate device, and it also been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
- Min. Turning Diameter, the proposed device has smaller min. turning diameter than predicate device, d. which is meet the design specification and has better flexibility than predicate device, and it also been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
- Seat Dimensions, the proposed device has different seat dimensions with predicate device, this e. specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
- f. Casters, the proposed device has different caster size and materials with predicate device, this specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
- Weight of wheelchair, the proposed device has different weight of wheelchair with predicate device, g. this different is caused by different framework design, but it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
| ITEM | Predicate Device (K163352) | Proposed Device | Remark |
|---|---|---|---|
| Performance Test | Comply with ISO | ||
| 7176-1/-3/-5/-7/-8/-11/-13/-15/-16/-22 | Comply with ISO | ||
| 7176-1/-3/-5/-7/-8/-11/-13/-15/-16/-22 | SE | ||
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label and | |||
| Labeling | Conforms to FDA Regulatory | ||
| Requirements | Conforms to FDA Regulatory | ||
| Requirements | SE |
| Table 3 Safety Comparison | ||
|---|---|---|
The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
8
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.