SHENGGUANG MANUAL WHEELCHAIR

K131529 · Pingdingshan Shenxing Healthcare Technology Co., L · IOR · Sep 24, 2013 · Physical Medicine

Device Facts

• Record ID: K131529
• Device Name: SHENGGUANG MANUAL WHEELCHAIR
• Applicant: Pingdingshan Shenxing Healthcare Technology Co., L
• Product Code: IOR · Physical Medicine
• Decision Date: Sep 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position. Shengguang Manual Wheelchair is not designed, sold, or intended for use except as indicated.

Device Story

Manual wheelchair for indoor/outdoor mobility; provides seated transport for individuals with limited mobility. Device features four-wheel base, seat, backrest, and manual handrims for user propulsion. Foldable design allows disassembly for transport. Operated by patient or caregiver. Healthcare provider uses device to facilitate patient mobility. Benefits include improved independence and accessibility for users restricted to seated position.

Clinical Evidence

Bench testing only. Compliance with ANSI/RESNA WC-1:2009 standards for static stability, brake effectiveness, dimensions/mass, seating/wheel dimensions, static/impact/fatigue strength, and coefficient of friction. Flammability testing performed per California Technical Bulletin 117. Biocompatibility assessed via material comparison to predicate devices.

Technological Characteristics

Manual wheelchair; welded steel tube frame; PVC/Oxford cloth upholstery; ABS armrest shells; Nylon handrims; Rubber brake handles. Features include cross-brace, foldable frame, and manual wheel locks. Tested per ANSI/RESNA WC-1:2009. Biocompatibility per FDA Guidance G95-1.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance. Suitable for indoor/outdoor use. No specific age or gender restrictions noted.

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

• Universal Wheelchair by Graham-Field Health Products, Inc. (K930411)
• 7000 Series Lightweight Wheelchairs by Nova Ortho-Med, Inc. (K061273)

Reference Devices

• YUYUE K2 Wheelchair (K120526)
• JUMAO MANUAL WHEELCHAIR (K082784)

Submission Summary (Full Text)

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K131529

# 510(K) SUMMARY

This 510(k) summary of safety and effectiveness for Shengguang Manual Wheelchair is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

| Applicant: | Pingdingshan Shenxing Healthcare Technology Co., Ltd. |
|----------------------|---------------------------------------------------------------------------------------------|
| Address: | Xinxing Road South of industrial Park, Lushan County,<br>Pingdingshan City Henan P.R. China |
| Contact Person: | Wang Qing |
| Telephone: | (86 0375)- 5620005 |
| Email: | [e-mail] |
| Date of Preparation: | Aug. 28, 2013 |
| Device Name: | SHENGGUANG MANUAL WHEELCHAIR |
| Classification Name: | Manual Wheelchair |
| Device Class: | Class I |
| Regulation Number | 890.3850 |
| Product Code: | IOR |
| Classification Panel | Physical Medicine |
| Type of submission | Traditional 510K |

Table 1 General Information

#### Intended use:

The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

#### Indications for Use:

The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position. Shengguang Manual Wheelchair is not designed, sold, or intended for use except as indicated.

### Device Description

The Shengguang Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistanceignitability fabric.

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All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in Predicate Devices.

#### Predicate Devices:

- Universal Wheelchair by Graham-Field Health Products, Inc. (Formerly Everest & Jennings), 510(k) # K930411.

- 7000 Series Lightweight Wheelchairs by Nova Ortho-Med, Inc., 510(k) # K061273.

#### Substantial Equivalence Discussion

Shenxing Healthcare Technology Co. believes that its Shengguang Manual Wheelchair is substantially equivalent to the Predicate Devices for the following reasons.

The Shengguang Manual Wheelchair has the same indication as the predicate device that it is intended for medical purposes to provide mobility to persons restricted to a seated position.

There are no significant differences between the specifications, functions and performance of Shengguang Manual Wheelchair and legally marketed predicate devices to which it is claimed to be substantially equivalent.

#### Summary of Substantial Equivalence Comparison

# Table 2: Descriptive Comparison of Shengguang Manual Wheelchair to Predict Devices

| ITEMS | SUBJECT DEVICE | | | | PREDICATE<br>DEVICE | PREDICATE<br>DEVICE | |
|-------------------------|---------------------------------------------------------|-------------------------------------------------------|------------------------------|----------------------|------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| BRAND NAME | SHENG<br>GUANG | SHENG<br>GUANG | SHENG<br>GUANG | SHENG<br>GUANG | Everest&Jenni<br>ngs | Nova | |
| MANUFACTURER | Pingdingshan Shenxing Healthcare<br>Technology Co., Ltd | | | | Graham-Field<br>Health<br>Products | Nova<br>Ortho-med Inc. | |
| MODEL NO | SG-LY-00<br>1001<br>(Fixed<br>armrest) | SG-LY-00<br>1016<br>(detachabl<br>e short<br>armrest) | SG-LY<br>-00101<br>7 | SG-LY<br>-00101<br>8 | Metro IC4<br>(3D020120)<br>(Universal<br>Wheelchair) | Nova<br>7160L/7180L | |
| 510K NO | | | | | K930411 | K061273 | |
| INTENDED USE | Same | Same | Same | Same | The device is<br>intended for<br>medical | To provide<br>mobility to adult<br>persons with | |
| | | | | | | purposes to<br>provide<br>mobility to<br>persons<br>restricted to a<br>seated position | limited mobility<br>or adult persons<br>limited to a<br>seated position.<br>(Over-The-Coun<br>ter Use) |
| | Primary<br>Material | Same | Same | Same | Same | Welded steel<br>tube | Welded steel<br>tube |
| | width | 16"/18"<br>(406mm/4<br>57mm/) | Same | Same | Same | 16"/18"/20"<br>(406mm/457m<br>m/508mm) | 16"/18"/20"<br>(406mm/457m<br>m/508mm) |
| | Cross brace | Same | Same | Same | Same | Yes | Yes |
| | Depth | 895mm | 895mm | 895mm | Same | 915mm | 915mm |
| frame | Seat | Same | Same | Same | Same | Width:16"/18"<br>/20"<br>(406mm/457m<br>m/508mm) | Width:16"/18"/<br>20"<br>(406mm/457m<br>m/508mm) |
| | | Same | Same | Same | Same | Depth<br>16"(406mm) | Depth<br>16"(406mm) |
| | Backrest<br>height | Fixed | Fixed | Fixed | Same | adjustable | adjustable |
| | Reclining<br>backrest | Same | Same | Same | Same | Fixed | Fixed |
| | Seat sling | Same | Same | Same | Same | Padded nylon | Padded nylon |
| | Frame colors | Same | Same | Same | Same | Black | Black |
| | Arm pad | Same | Same | Same | Same | Padded | Padded |
| Armrest | Flip back | Fixed | Detachable | Detach-<br>able | Same | Flip back | Flip back |
| | Height-adjusta<br>ble | Same | Same | Same | Same | No | No |
| | Swing-away | Same | Same | Same | Same | Yes | Yes |
| HANGERS | Elevating leg<br>rest | Same | Same | Same | Same | Yes | Yes |
| | Articulating<br>leg rest | Same | Same | Same | Same | No | No |
| | Footplate style | Same | Same | Same | Same | PA | PA |
| | Heel loop | Same | Same | Same | Same | No | No |
| | Footrest angle | Same | Same | Same | Same | 20° | 20° |
| | Offset axle | Same | Same | Same | Same | No | No |
| REAR | | | | | | | |
| AXLE | Quick-release<br>axle | Same | Same | Same | Same | No | No |
| | Whorl | Same | Same | Same | Same | Yes | Yes |
| REAR<br>WHEEL | Size | | Same | Same | Same | 24" | 24" |
| | Tire type | Same | Same | Same | Same | Solid<br>nylon | Solid<br>Nylon |
| | Handrim<br>material | Same | Same | Same | Same | | |
| | | | | | | | |
| CASTERS | Size | Same | Same | Same | Same | | 8" |
| | Tire type | Same | Same | Same | Same | | Solid |
| WHEEL LOCK | | Same | Same | Same | Same | Manual | Manual |
| Upholstery Material | | PVC<br>(Same as<br>GF Vista) | PVC<br>(Same as<br>GF Vista) | Same | Same | .Nylon | Nylon |
| WEIGHT CAPACITY | | 250lbs | 250lbs | Same | Same | 300lbs/136kg | 300lbs/136kg |
| WEIGHT OF CHAIR | | 17.3kg<br>(38lb) | 18.6kg<br>(41lb) | 17.3kg<br>(38lb) | Same | 15.5kg(34lb) | 15.5kg(34lb) |
| WARRANTY | | Same | Same | Same | Same | 5 years on<br>frame | 5 years on frame |
| OPTIONAL<br>ACCESSORIES | Anti-tipp<br>er | No | No | No | Same | Yes | Yes |

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The Shengguang Manual Wheelchair and the predicate devices employ the same technology and are similar in design, dimensions and other technological features. As seen in Table 2, the only differences in features between the Shengguang Manual Wheelchair and the predicate Devices are small differences in the weight of the wheelchair, style of the backrest height and armrest. These differences do not affect the safety and effectiveness of the Shengguang Manual Wheelchair compared to the predicate device.

#### Technological/Safety Characteristics and Performance Testing

The Shengguang Manual Wheelchair's technological and safety characteristics are identical to those described in the Predicate Devices.

Non-clinical testing has been performed on the Shengguang Manual Wheelchair and the results demonstrate compliance with the following standards:

ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability

ANSI/RESNA WC-1:2009 Section3: Determination of effectiveness of brakes

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ANSI/RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space

ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions

ANSI/RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strengths

ANSI/RESNA WC-1:2009 Section 11: Test dummies

ANSI/RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces

ANSI/RESNA WC-1:2009 Section 15: Requirements for information disclosure, documentation and labeling

The upholstery material for the SG-LY-001001/ SG-LY-001016 and SG-LY-001017/SG-LY-001018 series is the same as those used for the Graham Field Vista model and the Graham Field Metro IC4 model, respectively. It was tested in accordance with the California Technical Bulletin 117 Section E Part 1 and was shown to be Class 1 - normal flammability.

The foam material for the seat cushion was tested for flammability in accordance with the California Technical Bulletin 117 Section A Part 1 and Section D Part 2, and was shown to meet the performance standards.

#### Biocompatibility

The patient contacting components of the Shengguang Manual Wheelchair use the same materials, have the same chemical composition, and are manufactured using the same process by the same suppliers, as those of the Predicate Devices. Therefore, the Shengguang Manual Wheelchair meets the biocompatibility requirements in accordance with FDA Guidance G95-1. The comparison is shown in Table 3a and Table 3b.

| Model | Parts | Material | Comparison Device | 510(k) NO. |
|----------------------------------------------|---------------|----------|------------------------|------------|
| Shengguang<br>Manual<br>Wheelchair<br>Series | Handgrip | PVC | YUYUE K2<br>Wheelchair | K120526 |
| | Armrest shell | ABS | YUYUE K2<br>Wheelchair | K120526 |
| | Handrim | Nylon | YUYUE K2<br>Wheelchair | K120526 |
| | Brake handle | Rubber | YUYUE K2<br>Wheelchair | K120526 |

Table 3a. Comparison with Predicate Device Parts:

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| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>The first and the last and the been the desires of the first and the | 89.77<br>neelchair<br>3 | STATUTE AND INCOME OF CHARACT AND THE PERSONAL PROPERTY<br>------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 10-40-440 |

Table 3b. Comparison with Predicate Device Parts:

| Model | Parts | Material | Comparison Device | 510(k) NO. |
|----------------------------------------------|--------------------------------|----------------------|----------------------------|------------|
| Shengguang<br>Manual<br>Wheelchair<br>Series | Upholstery of<br>seat and back | Oxford<br>cloth, PVC | YUYUE K2, K4<br>Wheelchair | K120526 |
| | | | JUMAO MANUAL<br>WHEELCHAIR | K082784 |

### Conclusion:

The data submitted in this 510(K) Premarket Notification supports the finding that this device is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Devices. Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### September 24, 2013

Pingdingshan Shenxing Healthcare Technology Co., LTD c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K131529

Trade/Device Name: Shengguang Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 11, 2013 Received: September 12, 2013

Dear Mr. Job:

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. 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 statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mark Job

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ___ X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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