(189 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and safety standards of a manual wheelchair, with no mention of AI or ML technologies.
No
The device is a manual wheelchair intended for mobility, not to treat or cure a medical condition.
No
The device is a manual wheelchair, intended to provide mobility to individuals, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a frame, footplate, 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 is to provide mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a manual wheelchair, which is a mechanical aid for mobility. It does not involve any reagents, instruments, or software used to examine specimens from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a medical device, specifically a mobility aid, but it falls under a different regulatory category than In Vitro Diagnostics.
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 (comma separated list FDA assigned to the subject device)
IOR
Device Description
The proposed device, Manual Wheelchair, driven by manual operation of rear tire, or pushed by caretaker.
This product is mainly designed to be used to take care of the disabled or elderly, it is driven by manual operation of rear tire, or pushed by caretaker.
The Manual Wheelchair consists of Frame, Footplate, Front castor, Rear wheel, Anti-tipper, Armrest, Brake, Central fork.
The Manual Wheelchair has four models: JR201, JR202, JR203, JR204.
- JR201: 6 inch front wheel and 22 inch rear tire, without height adjustable armrest, flip-up armrest, detachable footrest, connecting brake
- JR202: 6 inch front wheel and 22 inch rear tire, with height adjustable armrest, flip-up armrest, detachable footrest, connecting brake
- JR203: 8 inch front wheel and 24 inch rear tire,, without height adjustable armrest, flip-up armrest, detachable footrest, connecting brake
- JR204: 8 inch front wheel and 24 inch rear tire, with height adjustable armrest, ● flip-up armrest, detachable footrest, connecting brake
Max. loading can not be over than 100Kgs.
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. Indicated patient group: Disabled and elderly people (less than 100kg)
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 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 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability
ISO 7176-3 Third edition 2012-12-15 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-5 Second edition 2008-06-01 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8 Second editon 2014-12-15 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
ISO 7176-13 First edition 1989-08-01 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
ISO 7176-22 Second edition 2014-09-01 Wheelchairs - Part 22: Set-up procedures
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.
No clinical study implemented for the mechanical wheelchair.
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.
March 30, 2020
Jerry Medical Instrument (Shanghai) Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, China 200120
Re: K192658
Trade/Device Name: Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: January 5, 2020 Received: February 20, 2020
Dear Boyle 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 avare 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 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,
Heather Dean, Ph.D. Acting Assistant Director 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) K192658
Device Name Manual Wheelchair
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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Address: Building 12, No. 615 Fengdeng Rd, Malu Town, Jiading District, Shanghai 201801, China Tel: 86-13817397985 Fax: 86-21-59517526 Contact: Jianguo Chen Date of Preparation: Sep.20, 2019
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Manual Wheelchair Common name: Mechanical Wheelchair Classification name: Wheelchair, Mechanical Model(s): JR201, JR202, JR203, JR204
3.0 Classification
Production code: IOR Regulation number: 21 CFR 890.3850 Classification: Class I Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD. Device: Manual Wheelchair 510(k) number: K180852
5.0 Indication for Use Statement
4
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
6.0 Device description
The proposed device, Manual Wheelchair, driven by manual operation of rear tire, or pushed by caretaker.
This product is mainly designed to be used to take care of the disabled or elderly, it is driven by manual operation of rear tire, or pushed by caretaker.
The Manual Wheelchair consists of Frame, Footplate, Front castor, Rear wheel, Anti-tipper, Armrest, Brake, Central fork.
The Manual Wheelchair has four models: JR201, JR202, JR203, JR204.
- JR201: 6 inch front wheel and 22 inch rear tire, without height adjustable armrest, flip-up armrest, detachable footrest, connecting brake
- JR202: 6 inch front wheel and 22 inch rear tire, with height adjustable armrest, flip-up armrest, detachable footrest, connecting brake
- JR203: 8 inch front wheel and 24 inch rear tire,, without height adjustable armrest, flip-up armrest, detachable footrest, connecting brake
- JR204: 8 inch front wheel and 24 inch rear tire, with height adjustable armrest, ● flip-up armrest, detachable footrest, connecting brake
Max. loading can not be over than 100Kgs.
7.0 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:
16-195 ISO 7176-1 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability 16-192 ISO 7176-3 Third edition 2012-12-15 Wheelchairs - Part 3: Determination of effectiveness of brakes 16-163 ISO 7176-5 Second edition 2008-06-01 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space 16-196 ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions 16-197 ISO 7176-8 Second editon 2014-12-15 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue
5
strengths
16-190 ISO 7176-11 Second edition 2012-12-01
Wheelchairs - Part 11: Test dummies
16-25 ISO 7176-13 First edition 1989-08-01
Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
16-27 ISO 7176-15 First edition 1996-11-15
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
16-191 ISO 7176-16 Second edition 2012-12-01
Wheelchairs - Part 16: Resistance to ignition of postural support devices
16-198 ISO 7176-22 Second edition 2014-09-01
Wheelchairs - Part 22: Set-up procedures
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.
8.0 Clinical Test Conclusion
No clinical study implemented for the mechanical wheelchair.
9.0 Technological Characteristic Comparison Table
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Product Code | IOR | IOR | SE |
| Regulation No. | 21 CFR 890.3850 | 21 CFR 890.3850 | SE |
| Class | I | I | SE |
| Product name | Manual Wheelchair | Manual Wheelchair | - |
| 510(k) No. | K180852 | - | |
| Models | JR201, JR202, JR203, | ||
| JR204 | XSG106A | - | |
| 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 | ||
| Use | |||
| environment | Indoor, outdoor | Indoor, outdoor | SE |
| Patient | |||
| Population | Disabled and elderly people | ||
| (less than 100kg) | Disabled or an elderly | ||
| person | * Gap 1 | ||
| Product | |||
| structure | Frame, Footplate, Front | ||
| castor, Rear wheel, | |||
| Anti-tipper, Armrest, Brake. | Frame, Footplate, Front | ||
| castor, Rear wheel, | |||
| Anti-tipper, Armrest, Brake. | SE |
Table1-General Comparison
6
| Central fork | |||
|---|---|---|---|
| Height adjustable | With height adjustable, or, without height adjustable | No height adjustable | *Gap 2 |
| Driving system | Driven by manual operation of rear tire, or pushed by caretaker. | Driven by manual operation of rear tire, or pushed by caretaker. | SE |
| Footplate | Yes | Yes | SE |
| Number of wheels | 4 | 4 | SE |
| Main frame material | Aluminium alloy | Aluminium alloy | SE |
- Gap analysis:
Gap 1: the two device share same target population, but the proposed device has stricter scope, only for whose weight is less than 100kg, which is defined in the product intended use, and the predicate device does not demonstrate this limit. After clarification in the product intended use, the difference can not raise additional safety concerns.
Gap 2: the models of JR201, JR202, JR203, R204 have difference in armrest type (with height adjustable, or, without height adjustable), the predicate device's armrest is without height adjustable. The difference in height adjustable does not bring additional safety and effectiveness concerns;
7
| Item | Table2 Performance Comparison
Proposed Device | | | | Predicate Device | Remark |
|---------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|----------|
| | JR201 | JR202 | JR203 | JR204 | | |
| Braking system | Connecting brake | | | | Connecting brake | SE |
| Max. loading
(kg) | 100 | | | | 100 | SE |
| Overall
dimensions | 1000530970
mm | 1000530970
mm | 1015655955
mm | 1015655955
mm | 1030640930 mm | * Gap 3 |
| Seat dimension | Depth:435 mm
Height:445 mm
Width:
410/450/510 mm | Depth:435 mm
Height:445 mm
Width:
410/450/510 mm | Depth:435 mm
Height:500 mm
Width:
410/450/510 mm | Depth:435 mm
Height:500 mm
Width:
410/450/510 mm | Depth: 460 mm
Height: 420 mm
Width: 410 mm | * Gap 4 |
| Rear wheel | Size: 22 inch
Tire: no
pneumatic | Size: 22 inch
Tire: no
pneumatic | Size: 24 inch
Tire: no
pneumatic | Size: 24 inch
Tire: no
pneumatic | Size: 610 mm
Tire: no pneumatic | * Gap 5 |
| Wheel lock | Push-to-Lock | Push-to-Lock | Push-to-Lock | Push-to-Lock | Pull-to-Lock | * Gap 6 |
| Ground
clearance | 70mm | 70mm | 70mm | 70mm | 150mm | * Gap 7 |
| Armrest | Without height
adjustable | Height adjustable | Without height
adjustable | Height adjustable | Without height adjustable | * Gap 8 |
| Casters (front
wheel) | Size: 6 inch | Size: 6 inch | Size: 8 inch | Size: 8 inch | Size: 200mm | * Gap 9 |
| Static stability
(forward, with
non-lockable
front wheels) | 15° | 15° | 15° | 15° | 17° | * Gap 10 |
| Static stability
(rearward, with
non-lockable
rear wheels) | 15° | 15° | 15° | 15° | 17° | * Gap 11 |
| Static stability
(rearward, with
lockable rear
wheels) | 13.1° | 13.1 ° | 13.1 ° | 13.1 ° | 16° | * Gap 12 |
| Static stability
(lateral forward,
Left/Right) | 15° | 15° | 15° | 15° | 16° | * Gap 13 |
| Parking brakes
(Facing
downhill, Facing
uphill) | 15° | 15° | 15° | 15° | 16° | * Gap 14 |
| Min. Turning
back diameter | 1700mm | 1700mm | 1700mm | 1700mm | 1700mm | SE |
| Net Weight | 14.8 kgs | 15 kgs | 16.3 kgs | 16.5 kgs | 18kg | * Gap 15 |
| Anti-tip wheels | Removable | Removable | Removable | Removable | Removable | SE |
| Suspension | No | No | No | No | No | SE |
Table2 Performance Comparison
8
- Gap analysis:
Gap 3-5, the two devices have different dimensions, rear wheel size, this specification is only affects the device, it could not affects the safety and effectiveness of proposed device are meet the design specification and been conducted into performance test, so the subject is as safe, as effective, and performs as well as the legally marketed prodicate device; Gap 6, the two devices have different wheel lock, which only influence the operation method: pull or push, it does not create additional safety and effectiveness concerns;
9
Gap 7, the two devices have different ground clearance, which impact the trafficability characteristic, but not affects the safety and effectiveness of proposed device, the ground clearance of proposed device is approved by its test report;
Gap 8, the models of JR201, JR202, R204 have difference in armrest adjusting (with height adjustable), the predicate device's armrest is without height adjustable, only lie one more function, does not bring additional safety and effectiveness concerns;
Gap 9, the different specification in caster size is only affects the appearance of the safety and effectiveness of proposed device;
Gap 10-14, the static stability of the proposed device, both of them is enough for usual using condition, the difference does not raise additional safety and effectiveness concerns;
Gap 15, the net weight of proposed device is lower than the predicate device, but is close, the difference does not raise and effectiveness concerns.
10
ltem Proposed Device Predicate Device Remark Performance test ISO 7176-1:2014, ISO 7176-1:2014, SE ISO 7176-3:2012. ISO 7176-3:2012, ISO 7176-5 :2008, ISO 7176-5 :2008, ISO 7176-7:1998, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-8:2014, ISO 7176-11:2012, ISO ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-13:1989, ISO 7176-15:1996, 7176-15:1996, ISO 7176-16:2012, ISO 7176-16:2012, ISO 7176-22:2014. ISO 7176-22:2014. * Gap 16 Main materials Frame, Anti-tip, Central Frame: Aluminium allov: fork: Aluminium alloy; Wheel, Armrest: PU; Armrest: PU; Rear Wheel: PU Solid Casters: Material Casters: PVC Solid PP+30%GF+PU; Material Rear wheel: hub+spoke(36 pcs) +aluminium alloy hand rim: Backrest: oxford cloth; Brake: Steel Materials Armrest: PU; * Gap 16 Armrests, Seat Base, Back Inner cushion: oxford Cover: Artificial leather contacting user cloth Comply with ISO SE Biocompatibility of Comply with ISO 10993-1, materials 10993-1, FDA Guidance, FDA Guidance, Tests contacting user Tests included included Cytotoxicity (ISO Cytotoxicity (ISO 10993-5:2009), 10993-5:2009), Sensitization and Sensitization and Intracutaneous Intracutaneous Reactivity (ISO Reactivity (ISO 10993-10:2010) 10993-10:2010) Conforms to FDA SE Label and Conforms to FDA Labeling Regulatory Requirements Regulatory Requirements
Table3 Safety Comparison
- Gap analysis:
Gap 16, the two devices have different materiasl on the Armrests, Seat Base, Back Cover, the two materials has passed the bio-compatibility tested on Cytotoxicity, Sensitization and Intracutaneous Reactivity based on the same test standards: ISO 10993-5:2009, and ISO 10993-10:2010; therefore, no safety and effectiveness concerns raised.
11
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness.The differences between both devices are insignificant in terms of safety and effectiveness.