(119 days)
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.
No.
A wheelchair is a mobility aid, not a therapeutic device. While it assists individuals with mobility limitations, it does not provide therapy in the sense of treating a disease or condition.
No
The device description indicates that the Shengguang Manual Wheelchair is intended for medical purposes to provide mobility, which is a therapeutic function, not a diagnostic one. It does not mention any capabilities to identify and/or characterize a disease or condition.
No
The device description clearly states it is a manual wheelchair with physical components like a base, wheels, and a seat, and the performance studies focus on physical properties and standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The provided information clearly states that the Shengguang Manual Wheelchair is intended to "provide mobility to persons restricted to a seated position." It is a physical device used for transportation and support.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic function.
The Shengguang Manual Wheelchair is a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
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.
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
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, |
| Pingdingshan City Henan P.R. China | |
| Contact Person: | Wang Qing |
| Telephone: | (86 0375)- 5620005 |
| Email: | kenwqing@gmail.com |
| 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.
1
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
DEVICE | PREDICATE
DEVICE | |
|-------------------------|---------------------------------------------------------|-------------------------------------------------------|------------------------------|----------------------|------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| BRAND NAME | SHENG
GUANG | SHENG
GUANG | SHENG
GUANG | SHENG
GUANG | Everest&Jenni
ngs | Nova | |
| MANUFACTURER | Pingdingshan Shenxing Healthcare
Technology Co., Ltd | | | | Graham-Field
Health
Products | Nova
Ortho-med Inc. | |
| MODEL NO | SG-LY-00
1001
(Fixed
armrest) | SG-LY-00
1016
(detachabl
e short
armrest) | SG-LY
-00101
7 | SG-LY
-00101
8 | Metro IC4
(3D020120)
(Universal
Wheelchair) | Nova
7160L/7180L | |
| 510K NO | | | | | K930411 | K061273 | |
| INTENDED USE | Same | Same | Same | Same | The device is
intended for
medical | To provide
mobility to adult
persons with | |
| | | | | | | purposes to
provide
mobility to
persons
restricted to a
seated position | limited mobility
or adult persons
limited to a
seated position.
(Over-The-Coun
ter Use) |
| | Primary
Material | Same | Same | Same | Same | Welded steel
tube | Welded steel
tube |
| | width | 16"/18"
(406mm/4
57mm/) | Same | Same | Same | 16"/18"/20"
(406mm/457m
m/508mm) | 16"/18"/20"
(406mm/457m
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"
/20"
(406mm/457m
m/508mm) | Width:16"/18"/
20"
(406mm/457m
m/508mm) |
| | | Same | Same | Same | Same | Depth
16"(406mm) | Depth
16"(406mm) |
| | Backrest
height | Fixed | Fixed | Fixed | Same | adjustable | adjustable |
| | Reclining
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-
able | Same | Flip back | Flip back |
| | Height-adjusta
ble | Same | Same | Same | Same | No | No |
| | Swing-away | Same | Same | Same | Same | Yes | Yes |
| HANGERS | Elevating leg
rest | Same | Same | Same | Same | Yes | Yes |
| | Articulating
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
axle | Same | Same | Same | Same | No | No |
| | Whorl | Same | Same | Same | Same | Yes | Yes |
| REAR
WHEEL | Size | | Same | Same | Same | 24" | 24" |
| | Tire type | Same | Same | Same | Same | Solid
nylon | Solid
Nylon |
| | Handrim
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
(Same as
GF Vista) | PVC
(Same as
GF Vista) | Same | Same | .Nylon | Nylon |
| WEIGHT CAPACITY | | 250lbs | 250lbs | Same | Same | 300lbs/136kg | 300lbs/136kg |
| WEIGHT OF CHAIR | | 17.3kg
(38lb) | 18.6kg
(41lb) | 17.3kg
(38lb) | Same | 15.5kg(34lb) | 15.5kg(34lb) |
| WARRANTY | | Same | Same | Same | Same | 5 years on
frame | 5 years on frame |
| OPTIONAL
ACCESSORIES | Anti-tipp
er | No | No | No | Same | Yes | Yes |
2
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:
3
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
4
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 | ||||
| Manual | ||||
| Wheelchair | ||||
| Series | Handgrip | PVC | YUYUE K2 | |
| Wheelchair | K120526 | |||
| Armrest shell | ABS | YUYUE K2 | ||
| Wheelchair | K120526 | |||
| Handrim | Nylon | YUYUE K2 | ||
| Wheelchair | K120526 | |||
| Brake handle | Rubber | YUYUE K2 | ||
| Wheelchair | K120526 |
Table 3a. Comparison with Predicate Device Parts:
5
| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The first and the last and the been the desires of the first and the | 89.77
neelchair
3 | STATUTE AND INCOME OF CHARACT AND THE PERSONAL PROPERTY
------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 10-40-440 |
Table 3b. Comparison with Predicate Device Parts:
| Model | Parts | Material | Comparison Device | 510(k) NO. |
|---|---|---|---|---|
| Shengguang | ||||
| Manual | ||||
| Wheelchair | ||||
| Series | Upholstery of | |||
| seat and back | Oxford | |||
| cloth, PVC | YUYUE K2, K4 | |||
| Wheelchair | K120526 | |||
| JUMAO MANUAL | ||||
| 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.
6
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
7
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
8
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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