AST Model MA012 and MS019 Rehab Wheelchair

K181795 · Sichuan Ast Medical Equipment Co., Ltd. · IOR · Sep 25, 2018 · Physical Medicine

Device Facts

• Record ID: K181795
• Device Name: AST Model MA012 and MS019 Rehab Wheelchair
• Applicant: Sichuan Ast Medical Equipment Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Sep 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.

Device Story

Manual wheelchairs (MA012, MS019) provide mobility for individuals limited to sitting. Features include foldable steel or aluminum frames, adjustable armrests, multiple axle positions, and shear reduction system (pivot point alignment). Casters (6"/7"/8" PU) and rear wheels (20"/22"/24" PU) facilitate movement. Operated by user or caregiver indoors/outdoors on dry, level surfaces (concrete, asphalt). Manual wheel locks prevent movement during parking. Output is physical mobility; healthcare providers use device to support patient independence and postural stability.

Clinical Evidence

Bench testing only. Compliance with ISO 7176 series (stability, brakes, dimensions, strength, fatigue, friction, labeling, ignition resistance) and ISO 10993 (cytotoxicity, irritation, sensitization) demonstrated performance equivalent to predicate.

Technological Characteristics

Manual, foldable frame (steel or aluminum). PU foam seat/backrest pads. Manual wheel locks. Adjustable armrests and multiple rear axle positions. Shear reduction system. Complies with ISO 7176-16:2012 (ignition resistance). No electronic components or software.

Indications for Use

Indicated for persons limited 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

• Invacare Tracer SX5 Manual Wheelchair (K162621)

Submission Summary (Full Text)

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September 25, 2018

Sichuan AST Medical Equipment Co., Ltd. Johnson Van Technical Sales Associate No.58, Jin-Peng Road, C Area, Luxian Industrial Park Luzhou City, Sichuan 646100 China

Re: K181795

Trade/Device Name: AST Model MA012 and MS019 Rehab Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: July 3, 2018 Received: July 5, 2018

Dear Johnson Van:

We have reviewed vour 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.

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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 and Part 809); 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.html; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181795

#### Device Name

AST Model MA012 and MS019 Rehab Wheelchair

#### Indications for Use (Describe)

The AST Model MA012 and MS019 Rehab Wheelchairs are 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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## 510(k) SUMMARY

Sichuan AST medical Equipment Co., Ltd. 510(k) Premarket Notification

#### Submitter:

Sichuan AST Medical Equipment Co., Ltd.

No.58, Jin-Peng Road, C Area, Luxian Industrial Park, Luzhou City, Sichuan, China, 646100

## Contact Person:

Johnson Van

Sichuan AST Medical Equipment Co., Ltd. No.58, Jin-Peng Road, C Area, Luxian Industrial Park, Luzhou City, Sichuan, China, 646100 Phone: [phone] Fax: [phone]

## Date Prepared:

June 2nd, 2018

### Proprietary Name:

AST Model MA012 and MS019 Rehab Wheelchair

### Common name:

Manual Wheelchair

### Classification name:

Mechanical Wheelchair, Class 1

### Product Code:

IOR

### Regulation Number:

21 CFR 890.3850

### Indications for Use

The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.

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# The Predicate Device:

This submission indicates the Substantial Equivalence of the AST Model MA012 and MS019 Rehab Wheelchair, with the predicate Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621). MA012 and MS019 have the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.

# Device Description

The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the

shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable.

The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel;

The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

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# Discussions of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:

| ISO 7176-1:2014 | Determination of Static Stability |
|-------------------|----------------------------------------------------------------------------------------------------|
| ISO 7176-3:2012 | Determination of effectiveness of brakes |
| ISO 7176-5:2008 | Determination of overall dimensions, mass and maneuvering<br>space |
| ISO 7176-7:1998 | Method of Measurement of Seating and Wheel Dimensions |
| ISO 7176-8:2014 | Requirements and test methods for static, impact and fatigue<br>strengths |
| ISO 7176-11:2012 | Test dummies |
| ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces |
| ISO 7176-15:1996 | Requirements for Information Disclosure, Documentation and<br>Labeling |
| ISO 7176-16:2012 | Resistance to ignition of postural support devices |
| ISO 14971:2007 | Medical devices -- Application of risk management to medical<br>devices |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

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# Comparison of the Technological Characteristics:

The AST Model MA012 and MS019 Rehab Wheelchair, is substantially equivalent to the Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 350lbs) mechanical wheelchair (K162621). Both products are mechanical designed for use as personal manual mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide mobility to persons limited to a sitting position. Additional, they are all constructed from the same basic materials, have the same basic operational principles or operated by others. The comparison table is as follow:

| Characteristics | | The AST Model<br>MS019 Rehab<br>Wheelchair(K18179<br>5) | The AST Model<br>MA012 Rehab<br>Wheelchair(K18179<br>5) | Invacare Tracer SX5<br>Manual Wheelchair<br>mechanical<br>wheelchair (K162621) |
|------------------------------|--------|------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for Use | | To provide mobility to<br>persons limited to a<br>sitting position. | To provide mobility to<br>persons limited to a<br>sitting position. | To provide mobility to<br>persons limited to a<br>sitting position. |
| Dimension | Length | 1196mm(±1mm) | 1173mm(±1mm) | 828mm(±1mm) |
| | Width | 775mm (±1mm) | 645mm (±1mm) | 762mm(±1mm) |
| | Height | 894mm (±1mm) | 892mm (±1mm) | 889mm(±1mm) |
| Weight | Total | 46 lbs | 38 lbs | 40 lbs |
| Weight Capacity | | 450 lbs | 300 lbs | 250/300 lbs |
| Seat width | | 18"/20"/22"/24" | 16"/18"/20" | 14"-22" |
| Seat height | | 19.8" | 19.7" | 17.5"-19.5" |
| Seat depth | | 18"-20" | 16"-20" | 18"-20" |
| Frame type | | foldable | foldable | foldable |
| Cross-brace<br>configuration | | 14 · , 16 · , 18 · , 20 · or<br>22 · | 14 · , 16 · , 18 · , 20 · or<br>22 · | 14 · , 16 · , 18 · , 20 · or<br>22 · |
| Back Style | | Fixed | Adjustable | Fixed |
| Anti-tippers | | Optional | Optional | Optional |
| Wheel<br>construction | | Fixed | Quick release | Fixed |
| Tires | | Front: 6",7",8"<br>Rear: 20",22",24" | Front: 6",7",8"<br>Rear: 20",22",24" | Front: 6",7",8"<br>Rear: 20",22",24" |
| Armrest | | Fixed or<br>adjustable<br>height; desk<br>or full length;<br>removable | Height Adjustable<br>desk length<br>armrest | Fixed or<br>adjustable<br>height; desk or<br>full length;<br>removable |
| Foot rest | | Optional/ swing away | Optional/ swing away | Optional/ swing away |
| Rear Axle Position | | Multiple | Multiple | Multiple |
| Frame Construction | | Foldable<br>frame | Foldable<br>frame | Fixed Frame<br>(Or foldable) |
| Frame Material | | Steel | Auminum | Steel |
| Safety Feature | | Manual Wheel Lock | Manual Wheel Lock | Manual Wheel Lock |

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The comparison of the technical details between MA012 and MS019 and its predicate device are summarized in the following:

- a. Dimension: The dimensions of our device and the predicate are similar. And our device conforms to the specific ISO test and that the results are disclosed to the user appropriately, as documented in the ISO standards for disclosure. So there is no deleterious affection of safety and effectiveness about the differences from the dimensions with the predicate device.
- b. Weight: Although the total weight bearing capacity of MA012 and MS019 is heavier than Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 350lbs) mechanical wheelchair (K162621). The device conforms to the specific ISO test and that the results are disclosed to the user appropriately, as documented in the ISO standards for disclosure (Requirements and test methods for static, impact and fatique strengths) test. So there is no deleterious affection of safety and effectiveness about the difference on weight bearing capacity with predicate device.
- ﻥ Both of our devices and the predicate are equipped with PU foam Seat/Backrest Pad, adjustable Headrest and Armrest. Our MA012 AND MS019 is supplied with a standard Elevating Legrest/Footrest, while the predicate device is provided it as an option. The Elevating Legrest/Footrest can provide better strain-relief for legs.
- d. Multiple Rear Axle Position: Both our MA012 AND MS019 and the predicate device are provided with Multiple Rear Axle Positions to allow users to change its seat height to a best fitting position.
- Frame Construction and material: Our MS019 and MA012 devices and the e. predicated device are the same foldable frames.
- Safety Feature: Both of our devices and the predicated device are equipped f. with Manual Wheel Locks to prevent unexpected movement while parking.

The minor differences between MA012 and MS019 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the MA012 and MS019 is substantially equivalent to the predicate device.

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# Conclusions

According to comparison table, the differences on weight capacity, adjustable back angle and dimensions do not deleteriously affect the safety and effectiveness of the device.

The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.

So based on the design, performance specifications and testing and intended use, The AST Model MA012 and MS019 Rehab Wheelchair, is substantially equivalent to the Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621).