(146 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard powered wheelchair controlled by a joystick. There is no mention of AI or ML capabilities for navigation, control, or any other function.
No.
The device is a powered wheelchair intended for mobility, not to treat or cure a medical condition.
No
The device is a powered wheelchair intended for transportation and mobility, not for diagnosing medical conditions. Its function is to assist individuals with mobility limitations.
No
The device description clearly outlines numerous hardware components including motors, wheels, batteries, frame, and a control panel, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a powered wheelchair with components related to mobility (motors, wheels, batteries, controls). There are no components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
Product codes
ITI
Device Description
The powered wheelchair DYW30A(D09) is driven by two DC motors, and is suitable for indoor uses. It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The powered wheelchair DYW30A(D09) comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable.
It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The device is powered by two 12 volt / 6 Ah Lithium-ion batteries with 11.2 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz), when the device is not in use.
The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of DYW30A(D09) is 264 lbs and its maximum speed is 3.75 mph.
The following surfaces are recommended NOT to operate on:
- Sand surface
- Wet or icy surface
- Road maintenance hole metal cover
- Do not use on stairs
- Do not use escalators. Use the elevator.
- Too steep incline over 8 degrees.
- Obstacle climbing ability: 1.36"
- Do not use outdoors
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)
Performance Testing:
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3:2013 Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength
- ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
- ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
Biocompatibility of patient-contacting material:
- Seat, Backrest, Safety belt, Joystick: PVC Vinyl. Rational for biocompatibility testing: ISO 10993-1:2009, PVC Vinyl material is adopted by many wheelchair manufacturers in the market, and it is common and mature material for wheelchair parts. No customer claim with adverse conditions for more than thousands of units sold in the market. Conclusion: We conduct the ISO 10993-5 and ISO 10993-10 tests.
- Armrest: PU Foam. Rational for biocompatibility testing: ISO 10993-1:2009, PU Foam material is adopted by many wheelchair manufacturers in the market, and it is common and mature material for wheelchair parts. No customer claim with adverse conditions for more than thousands of units sold in the market. Conclusion: We conduct the ISO 10993-5 and ISO 10993-10. tests.
DYW30A(D09) has passed the relevant testing, including ISO 7176 series and IEC 60601-1-2:2014, to ensure there are no new safety and effectiveness concerns when compared with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for JBH Wheelchair. The logo has a green letter "D" on the left side. To the right of the "D" is the text "JBH Wheelchair" in orange. Below the text is the phrase "Portable, Light, Safe".
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106 Tel: 0086(25)85780699 Fax: 00861860 556 5636 Email: njjbhch@gmail.com Website: www.jbhwheelchair.com
510(k) Summary of Safety and Effectiveness 5.
(per 21 CFR 807.92)
| Submitter's Name: | Nanjing Jin Bai He Medical Apparatus Co., Ltd.
No. 61 Qinhuai Road, Jiangning Economic and Technological
Development Zone, Nanjing, Jiangsu, China 211106 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date summary prepared: | July 5, 2017 |
| Proprietary Name: | Powered Wheelchair, DYW30A(D09) |
| Common or Usual Name: | Powered Wheelchair |
| Classification Name: | Powered Wheelchair, Class II, 21 CFR 890.3860 |
| Product Code: | ITI |
| Company contact person: | Dr. KE-MIN JEN (Email: ceirs.jen@msa.hinet.net)
TEL: +886-3-5208829, FAX:+886-3-5209783 |
| Predicate Device: | SUZHOU KD MEDICAL APPLIANCE CO. LTD.
PL001 power wheelchair
K113463 |
● Indications for Use:
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
● Device Description:
The powered wheelchair DYW30A(D09) is driven by two DC motors, and is suitable for indoor uses. It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The powered wheelchair DYW30A(D09) comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable.
It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
1
Image /page/1/Picture/0 description: The image contains the logo for JBH Wheelchair. The logo features a green stylized letter "D" on the left, followed by the text "JBH Wheelchair" in orange. Below the text, there is a tagline that reads "Portable, Light, Safe".
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106 Tel: 0086(25)85780699 Fax: 00861860 556 5636 Email: njjbhch@gmail.com Website: www.jbhwheelchair.com
The device is powered by two 12 volt / 6 Ah Lithium-ion batteries with 11.2 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz), when the device is not in use.
The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of DYW30A(D09) is 264 lbs and its maximum speed is 3.75 mph.
The following surfaces are recommended NOT to operate on:
- Sand surface �
- Wet or icy surface ◆
- Road maintenance hole metal cover �
- � Do not use on stairs
- � Do not use escalators. Use the elevator.
- ◆ Too steep incline over 8 degrees.
- Obstacle climbing ability: 1.36"
- Do not use outdoors
2
Image /page/2/Picture/0 description: The image is a logo for JBH Wheelchair. The logo features a green letter "D" with a small orange accent at the top. To the right of the "D" is the text "JBH Wheelchair" in orange. Below the text is the phrase "Portable, Light, Safe" in a smaller font, also in orange.
No. 61 Oinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106 Tel: 0086(25)85780699 Fax: 00861860 556 5636 Email: njjbhch@gmail.com Website: www.jbhwheelchair.com
● Performance Testing:
- v ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- v ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- く ISO 7176-3:2013 Wheelchairs - Part 3: Determination of effectiveness of brakes
- v ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- V ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- V ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- V ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- V ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength
- v ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- V ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- V ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- V ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- V ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- V ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
3
Image /page/3/Picture/0 description: The image contains the logo for JBH Wheelchair. The logo features a green stylized letter "D" with a smaller green symbol below it. To the right of the "D" is the text "JBH Wheelchair" in orange. Below the text is the phrase "Portable, Light, Safe" also in orange.
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106 Tel: 0086(25)85780699 Fax: 00861860 556 5636 Email: njjbhch@gmail.com Website: www.jbhwheelchair.com
- V ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
- イ ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- く ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
- V IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- V IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
| Patient-contacting parts | Materials | Rational for biocompatibility testing | Conclusion |
|---|---|---|---|
| Seat | |||
| Backrest | |||
| Safety belt | |||
| Joystick | PVC Vinyl | *ISO 10993-1:2009 | |
| *PVC Vinyl material is adopted by many | |||
| wheelchair manufacturers in the market, and | |||
| it is common and mature material for | |||
| wheelchair parts. | |||
| *No customer claim with adverse conditions | |||
| for more than thousands of units sold in the | |||
| market. | We conduct the | ||
| ISO 10993-5 | |||
| and ISO | |||
| 10993-10 tests. | |||
| Armrest | PU Foam | *ISO 10993-1:2009 | |
| *PU Foam material is adopted by many | |||
| wheelchair manufacturers in the market, and | |||
| it is common and mature material for | |||
| wheelchair parts. | |||
| *No customer claim with adverse conditions | |||
| for more than thousands of units sold in the | |||
| market. | We conduct the | ||
| ISO 10993-5 | |||
| and ISO | |||
| 10993-10. tests. |
● Biocompatibility of patient-contacting material
4
Image /page/4/Picture/0 description: The image shows the logo for JBH Wheelchair. The logo features a green stylized letter "J" next to the orange text "JBH Wheelchair". Below the text is the tagline "Portable, Light, Safe" in a smaller font. The logo is clean and modern, with a focus on the brand name and its key attributes.
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106
il: njjbhch@gmail.com Website: www.jbhwheelchair.com
| ● | Comparison table | ||
|---|---|---|---|
| Devices | |||
| Specifications | Predicate device | Subject device | Explaining no new |
| safety and effectiveness | |||
| concerns raised due to | |||
| the differences | |||
| Manufacturer | Suzhou KD Medical | ||
| Apparatus Co., Ltd. | Nanjing Jin Bai He | ||
| Medical Apparatus Co., | |||
| Ltd. | Devices made by | ||
| different manufacturers | |||
| Proprietary name | Power Wheelchair | Powered Wheelchair, | Different devices |
| Model name | PL001 | DYW30A(D09) | Different models |
| 510(k) No. | K113463 | K170787 | New 510(k) submission |
| Similarities | |||
| Indications for use | The device is a motor | ||
| driven. indoor and | |||
| outdoor transportation | |||
| vehicle with the | |||
| intended use to Provide | |||
| mobility to a disabled or | |||
| elderly person limited to a | |||
| seated | |||
| position | The device is a motor- | ||
| driven, and indoor | |||
| transportation vehicle | |||
| with the intended use to | |||
| provide mobility to a | |||
| disabled or an elderly | |||
| person limited to a seated | |||
| position. | The PL001 is for indoor | ||
| and outdoor uses and the | |||
| DYW30A(D09) is for | |||
| indoor use. | |||
| The restriction in indoor | |||
| use can decrease the risk | |||
| level for the subject | |||
| device, thus ensure no | |||
| new safety and | |||
| effectiveness concerns | |||
| raised due to the | |||
| difference. | |||
| Motor | Chongqing Mao Tian | ||
| Machinery Co., Ltd., | |||
| Brushless DC motor | |||
| $180 W×24 VDCx2 pcs$ | Chongqing Mao Tian | ||
| Machinery Co., Ltd., | |||
| Brushless DC motor | |||
| $250W x 24 VDC x 2 pcs$ | Similar motors are made | ||
| by the same company. | |||
| Our motor power is | |||
| larger than predicate | |||
| device, and this means | |||
| more driving force are | |||
| supplied to the subject | |||
| device, no safety and | |||
| effectiveness concerns | |||
| raised. | |||
| Battery | Jiangsu Feng Chi Green | ||
| Power Supply Co., Ltd., | |||
| Lithium-ion | |||
| $10Ahx24 VDCx2 pcs$ | Jiangsu Feng Chi Green | ||
| Power Supply Co., Ltd., | |||
| Lithium-ion, ITP2406 | |||
| $6 Ah x 24 VDC x 2 pcs$ | Similar batteries are | ||
| made by the same | |||
| manufacturer. | |||
| Our battery meets ISO |
5
Image /page/5/Picture/0 description: The image is a logo for JBH Wheelchair. The logo features a green letter "D" with the letters "JBH" in a smaller font below it. To the right of the "D" is the word "Wheelchair" in orange. Below the word "Wheelchair" is the phrase "Portable, Light, Safe" in a smaller font.
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD.
9331 — Pateller Life Sale — NANING JIN BAL HE MEDICAL APPARATUS CO., LTD.
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China Ema
| ﺭ | ail: njjbhch(@gmail.com Website: www.jbhwheelchair.com |
|---|---|
| --- | -------------------------------------------------------- |
| Email: njjbhch@gmail.com Website: www.jbhwheelchair.com | | | 7176-25:2013, and no
new safety and
effectiveness concerns
raised. |
|---------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Charger model &
rating | High Power Technology
Inc.
HP1202B
Input: AC100-240V
Output: DC 24V, 2Amp | High Power Technology
Inc.
HP0060W(L2)
Input: 100-240 VAC
Output: DC 24V, 2 Amp | Similar chargers are
made by the same
manufacturer. Our
charger meets ISO
7176-25:2013, and no
new safety and
effectiveness concerns
raised. |
| | | | |
| Number of Wheels | 4 | 4 | Same number of wheels |
| Driving system | Direct drive on the rear
wheels | Direct drive on the rear
wheels | Same driving system |
| Brake System | Smart Electromagnetic
brake | Smart Electromagnetic
brake | Same brake system |
| Max Speed
(Forwards) | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same maximum speed,
forward |
| Speed control
method | Joystick control method | Joystick control method | Same speed control
method |
| Main frame
material | 6063 aluminum alloy | 6063 aluminum alloy | Same frame material |
| | | Differences | |
| Use environments | Indoor and outdoor use | Indoor use | Restricted use in the
indoor environment will
ensure lower risk level. |
| Front wheel size &
type | 6" x 2" (150×38 mm)
(PU Solid tire) | 7"x1.77" (180 x 45 mm)
(PU solid tire) | Larger sizes of front
wheels bring steadier
pivoting function than
predicate device. |
| Rear wheel size &
type | 8" x 2"
(200 x 50 mm)
(PU solid tire) | 12.5" x 2.25"
(320 x 57 mm)
(PU solid tire) | Larger sizes of rear
wheels bring more
comfortable ride feeling
than predicate device. |
| Maximum safe
operational incline | 12 degrees | 8 degrees | We restrict the use
environment for the
subject device to be
indoor. Safe operational |
6
Image /page/6/Picture/0 description: The image shows the logo for JBH Wheelchair. The logo features a stylized letter "D" in green, with the letters "JBH" in orange to the right of the "D". The word "Wheelchair" is also in orange and is placed to the right of "JBH". Below the company name is the text "Portable, Light, Safe".
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD.
1991 - 1978 - 1978 - 1978 - 1978 - 1978 - 1974 - 1974 - 1974 - 1974 - 1974 - 1979 - 1970.
No. 61 Qinhuai Road, Jan - 1990 - 1992 - 1996 (25 - 563 - 1986 1860 556 - 565 -E
| Email: njjbhch@gmail.com Website: www.jbhwheelchair.com |
|---|
| --------------------------------------------------------- |
| Email: njjbhch@gmail.com Website: www.jbhwheelchair.com | |||
|---|---|---|---|
| Dimensions | |||
| (LxWxH) | 38.2" x 23.2" x 33.1" | 37.4" x 22.6" x 36.2" | incline of 8 degrees for |
| the DYW30A(D09) is | |||
| enough for indoor use. | |||
| No new safety and | |||
| effectiveness concerns | |||
| are raised by this | |||
| difference. | |||
| Minor differences in the | |||
| dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Weight, w/ Battery | 60.87 lbs. / 27.6 kg | 51.8" lbs. / 23.5 kg | Less weight will lead to |
| more convenience when | |||
| transported and there is | |||
| more cruising range than | |||
| predicate device. | |||
| Cruising Range | 9.3 miles (15 km) | 11.2 miles (18 km) | This difference is due to |
| the less weight and more | |||
| power for the subject | |||
| device, based on the | |||
| work and energy | |||
| theorem. There is a | |||
| larger cruising range for | |||
| the subject device. | |||
| Max Loading | 250 lbs. | 264 lbs. | More loading weight |
| means more convenient | |||
| for the transportation. | |||
| Max Speed | |||
| Backward | 2.4 mph (3.84 km/h) | 1.86 mph (3.0 km/h) | Smaller backward speed |
| means lower risk level | |||
| for the subject device. | |||
| Turning Radius | 31.5" (800 mm) | 32.5" (833 mm) | The minor difference in |
| the turning radius will | |||
| cause some | |||
| inconvenience when it | |||
| turns in a narrow space | |||
| and the difference will | |||
| not raise any new safety | |||
| and effectiveness | |||
| concerns | |||
| Maximum obstacle | |||
| climbing | 1.2" (30 mm) | 1.36" (34.5 mm) | The larger height in the |
| obstacle climbing will | |||
| not impact the safety | |||
| and effectiveness of the | |||
| subject device. | |||
| Controller | Brushless dual-drive rocker | ||
| controller | Changzhou Billon | ||
| Electronic Appliance Co., | |||
| Ltd., WS-1 | Our controller passed | ||
| ISO 7176-14 and there | |||
| is no safety and | |||
| effectiveness concerns | |||
| raised due to this | |||
| difference. | |||
| Minimum braking | |||
| distance | 1.5 m | 1 m | Our minimum braking |
| distance is smaller than | |||
| the predicate device and | |||
| this ensures more safety. | |||
| There is no new safety | |||
| and effectiveness | |||
| concerns raised due to | |||
| the difference. |
7
Image /page/7/Picture/0 description: The image is a logo for JBH Wheelchair. The logo features the letters "JBH" in green and orange, with the word "Wheelchair" in orange next to it. Below the text is the phrase "Portable, Light, Safe" in orange. The logo is simple and modern, and it conveys the message that JBH Wheelchair is a company that provides high-quality, portable, light, and safe wheelchairs.
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106 Tel: 0086(25)85780699 Fax: 00861860 556 5636
● Substantial equivalent discussion
Firstly please refer to the explanations in the comparison table. The engineering design and technical properties of DYW30A(D09) powered wheelchair are very similar to the predicate device, PL001 power wheelchair. Both chairs utilize dual brushless motors as their power sources, and the motors are manufactured by the same company, while PL001 uses 180W motors, DYW30A(D09) uses 250W motors.
The Lithium-ion batteries used by both powered wheelchairs come from the same manufacturer as well, though PL001 power wheelchair uses 10Ah batteries and DYW30A(D09) powered wheelchair uses 6Ah batteries. The maximum speed of DYW30A(D09) is the same as the predicate device.
The control system, including the joystick controller, the smart electromagnetic brakes and their user interface are similar. The joystick controls the directions of the powered wheelchair, move the joystick in the direction that the user is looking to go, and when the joystick is released, the powered wheelchair will come to a stop slowly, and the brakes will automatically re-engage. The control system of the subject device passed the ISO 7176-14:2008 and there are no new safety and effectiveness concerns due to the difference.
8
Image /page/8/Picture/0 description: The image shows the logo for JBH Wheelchair. The logo features a stylized letter "D" in green, followed by the text "JBH Wheelchair" in orange. Below the text, there is a tagline that reads "Portable, Light, Safe".
No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone, Nanjing, Jiangsu, China 211106 Tel: 0086(25)85780699 Fax: 00861860 556 5636 Email: njjbhch@gmail.com Website: www.jbhwheelchair.com
The turning radius of the subject device is larger than that of the predicate device by 1.0". This difference will bring slight inconvenience to the user of the subject device while doing a turning in the limited space, but this is not related to the safety aspect.
Other minor differences between two powered wheelchairs include weights, overall dimensions and maximum weight capacity, and these do not change the overall functions and intended uses of the DYW30A(D09).
DYW30A(D09) has passed the relevant testing, including ISO 7176 series and IEC 60601-1-2:2014, to ensure there are no new safety and effectiveness concerns when compared with the predicate device.
Image /page/8/Picture/6 description: The image shows a black electric wheelchair with a silver frame. The wheelchair has a padded seat and backrest, as well as armrests and a footrest. A joystick is mounted on the right armrest, which is used to control the wheelchair's movement. The wheelchair has four wheels, with the two front wheels being smaller than the two rear wheels.
Predicate device: PL001 power wheelchair
Image /page/8/Picture/8 description: The image shows a red and black electric wheelchair. The wheelchair has a black seat and backrest, and a red frame. It has a joystick control on the left armrest. The wheelchair is sitting on a gray floor.
Subject device: DYW30A(D09) powered wheelchair
● CONCLUSIONS
The subject device, DYW30A(D09), is as safe and effective as, and functions in a manner equivalent to the predicate device, PL001 (K113463). The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate device.
9
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10
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
Nanjing Jin Bai He Medical Apparatus Co., Ltd. Jen Ke-Min Official Correspondent No. 61 Qinhuai Road, Jiangning Economic and Technological Development Zone Nanjing, 211106 CN
Re: K170787
Trade/Device Name: Powered Wheelchair DYW30A(D09) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 10, 2017 Received: March 16, 2017
Dear Jen Ke-Min:
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
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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); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure