Manual Wheelchair

K192658 · Jerry Medical Instrument (Shanghai) Co., Ltd. · IOR · Apr 1, 2020 · Physical Medicine

Device Facts

• Record ID: K192658
• Device Name: Manual Wheelchair
• Applicant: Jerry Medical Instrument (Shanghai) Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Apr 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Story

Manual wheelchair for disabled or elderly individuals; provides mobility via manual operation of rear tires by user or pushing by caretaker. Consists of frame, footplate, front castors, rear wheels, anti-tippers, armrests, and brakes. Available in four models (JR201-JR204) with variations in wheel size (6/8-inch front, 22/24-inch rear) and armrest adjustability. Used in indoor and outdoor environments. Provides mobility support to improve patient independence and facilitate caregiving. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against ISO 7176 standards (stability, braking, dimensions, fatigue, ignition resistance) and biocompatibility standards (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Manual wheelchair; aluminum alloy frame; PU/PVC/Oxford cloth components. Dimensions vary by model. No energy source; manual operation. Biocompatibility per ISO 10993-1. Testing per ISO 7176-1, 3, 5, 7, 8, 11, 13, 15, 16, 22.

Indications for Use

Indicated for disabled and elderly persons (weight < 100kg) restricted to a sitting position requiring mobility assistance.

Regulatory Classification

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.

Predicate Devices

• Manual Wheelchair (K180852)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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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# 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: [phone] Fax: [phone] 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: [phone] Email: [e-mail]

### 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

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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

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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,<br>JR204 | XSG106A | - |
| Intended Use | The device is intended for<br>medical purposes to provide<br>mobility to persons<br>restricted to a sitting<br>position | The device is intended for<br>medical purposes to provide<br>mobility to persons<br>restricted to a sitting<br>position. | SE |
| Use<br>environment | Indoor, outdoor | Indoor, outdoor | SE |
| Patient<br>Population | Disabled and elderly people<br>(less than 100kg) | Disabled or an elderly<br>person | * Gap 1 |
| Product<br>structure | Frame, Footplate, Front<br>castor, Rear wheel,<br>Anti-tipper, Armrest, Brake. | Frame, Footplate, Front<br>castor, Rear wheel,<br>Anti-tipper, Armrest, Brake. | SE |

#### Table1-General Comparison

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| | 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;

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| Item | Table2 Performance Comparison<br>Proposed Device | | | | Predicate Device | Remark |
|---------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|----------|
| | JR201 | JR202 | JR203 | JR204 | | |
| Braking system | Connecting brake | | | | Connecting brake | SE |
| Max. loading<br>(kg) | 100 | | | | 100 | SE |
| Overall<br>dimensions | 1000*530*970<br>mm | 1000*530*970<br>mm | 1015*655*955<br>mm | 1015*655*955<br>mm | 1030*640*930 mm | * Gap 3 |
| Seat dimension | Depth:435 mm<br>Height:445 mm<br>Width:<br>410/450/510 mm | Depth:435 mm<br>Height:445 mm<br>Width:<br>410/450/510 mm | Depth:435 mm<br>Height:500 mm<br>Width:<br>410/450/510 mm | Depth:435 mm<br>Height:500 mm<br>Width:<br>410/450/510 mm | Depth: 460 mm<br>Height: 420 mm<br>Width: 410 mm | * Gap 4 |
| Rear wheel | Size: 22 inch<br>Tire: no<br>pneumatic | Size: 22 inch<br>Tire: no<br>pneumatic | Size: 24 inch<br>Tire: no<br>pneumatic | Size: 24 inch<br>Tire: no<br>pneumatic | Size: 610 mm<br>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<br>clearance | 70mm | 70mm | 70mm | 70mm | 150mm | * Gap 7 |
| Armrest | Without height<br>adjustable | Height adjustable | Without height<br>adjustable | Height adjustable | Without height adjustable | * Gap 8 |
| Casters (front<br>wheel) | Size: 6 inch | Size: 6 inch | Size: 8 inch | Size: 8 inch | Size: 200mm | * Gap 9 |
| Static stability<br>(forward, with<br>non-lockable<br>front wheels) | 15° | 15° | 15° | 15° | 17° | * Gap 10 |
| Static stability<br>(rearward, with<br>non-lockable<br>rear wheels) | 15° | 15° | 15° | 15° | 17° | * Gap 11 |
| Static stability<br>(rearward, with<br>lockable rear<br>wheels) | 13.1° | 13.1 ° | 13.1 ° | 13.1 ° | 16° | * Gap 12 |
| Static stability<br>(lateral forward,<br>Left/Right) | 15° | 15° | 15° | 15° | 16° | * Gap 13 |
| Parking brakes<br>(Facing<br>downhill, Facing<br>uphill) | 15° | 15° | 15° | 15° | 16° | * Gap 14 |
| Min. Turning<br>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

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* 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;

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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.

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#### 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.

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#### 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.