(146 days)
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 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 provided document is a 510(k) summary for a Powered Wheelchair (DYW30A(D09)). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study of an AI/algorithm-based device and its acceptance criteria as requested in the prompt.
Therefore, many of the specific questions regarding acceptance criteria and study methodologies for an AI/algorithm-based device (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) cannot be answered from the provided text.
The document primarily addresses the safety and effectiveness of a physical medical device (a powered wheelchair) through performance testing against established ISO and IEC standards, and a comparison to a predicate device.
However, I can extract the information relevant to the performance testing and comparison aspects that serve as the "acceptance criteria" for this specific medical device.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for this medical device are based on compliance with a comprehensive set of international standards (ISO and IEC) for wheelchairs. The document reports that the device "passed" these tests, implying compliance with the requirements within those standards. The specific performance values are not always listed as "reported device performance" in a separate row but are implicitly confirmed by passing the tests and in the comparison table.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Implied by "Passed" / Stated in Comparison) |
|---|---|
| ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability | Passed |
| ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | Passed |
| ISO 7176-3:2013 Wheelchairs - Part 3: Determination of effectiveness of brakes | Passed (Minimum braking distance: 1m, which is smaller/better than predicate's 1.5m) |
| ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Passed (Cruising Range: 11.2 miles (18 km), which is larger than predicate's 9.3 miles) |
| ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space | Passed (Dimensions: 37.4" x 22.6" x 36.2"; Weight: 51.8 lbs / 23.5 kg) |
| ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Passed (Max Speed Forwards: 3.75 mph (6 km/h); Max Speed Backward: 1.86 mph (3.0 km/h)) |
| ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Passed (Front wheel: 7"x1.77"; Rear wheel: 12.5"x2.25") |
| ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength | Passed |
| ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs | Passed |
| ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Passed (Maximum obstacle climbing: 1.36" (34.5 mm)) |
| ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies | Passed |
| ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | Passed |
| ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Passed (Controller: Changzhou Billon Electronic Appliance Co., Ltd., WS-1) |
| ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | Passed |
| ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices | Passed |
| ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters | Passed |
| ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs | Passed (Battery: Lithium-ion, 6 Ah x 24 VDC x 2 pcs; Charger: High Power Technology Inc., HP0060W(L2)) |
| 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 | Passed |
| IEC 662133:2012 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 | Passed |
| Biocompatibility Testing (ISO 10993-5 and ISO 10993-10) for patient-contacting parts (Seat, Backrest, Safety belt, Joystick, Armrest) | Conducted (implies passed for PVC Vinyl and PU Foam, with rationale based on common use and no adverse claims for thousands of units sold in market). |
| Maximum Safe Operational Incline | 8 degrees (restricted from predicate's 12 degrees, deemed sufficient for indoor use) |
| Max Loading | 264 lbs (compared to predicate's 250 lbs) |
| Turning Radius | 32.5" (833 mm) (compared to predicate's 31.5", difference deemed minor inconvenience, not safety concern) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the performance tests. Typically, device testing standards involve a certain number of units or test cycles, but this is not detailed in the summary.
- Data Provenance: The testing was conducted by or on behalf of Nanjing Jin Bai He Medical Apparatus Co., Ltd. in Nanjing, Jiangsu, China. The document is a summary of findings, not raw data. The testing is assumed to be prospective as it's to demonstrate compliance for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a physical product being tested against engineering standards, not an AI/algorithm-based diagnostic tool requiring expert consensus for ground truth. The "ground truth" is established by the specifications and measurement methodologies defined in the listed ISO and IEC standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for physical device performance testing against engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a powered wheelchair, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device comes from the established and recognized international standards (ISO and IEC) for wheelchair performance and safety. These standards define the test methods, acceptance limits, and measurement criteria.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
{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 TechnologicalDevelopment 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 wheelchairK113463 |
● 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 |
|---|---|---|---|
| SeatBackrestSafety beltJoystick | PVC Vinyl | *ISO 10993-1:2009*PVC Vinyl material is adopted by manywheelchair manufacturers in the market, andit is common and mature material forwheelchair parts.*No customer claim with adverse conditionsfor more than thousands of units sold in themarket. | We conduct theISO 10993-5and ISO10993-10 tests. |
| Armrest | PU Foam | *ISO 10993-1:2009*PU Foam material is adopted by manywheelchair manufacturers in the market, andit is common and mature material forwheelchair parts.*No customer claim with adverse conditionsfor more than thousands of units sold in themarket. | We conduct theISO 10993-5and ISO10993-10. 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 | ||
|---|---|---|---|
| DevicesSpecifications | Predicate device | Subject device | Explaining no newsafety and effectivenessconcerns raised due tothe differences |
| Manufacturer | Suzhou KD MedicalApparatus Co., Ltd. | Nanjing Jin Bai HeMedical Apparatus Co.,Ltd. | Devices made bydifferent 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 motordriven. indoor andoutdoor transportationvehicle with theintended use to Providemobility to a disabled orelderly person limited to aseatedposition | The device is a motor-driven, and indoortransportation vehiclewith the intended use toprovide mobility to adisabled or an elderlyperson limited to a seatedposition. | The PL001 is for indoorand outdoor uses and theDYW30A(D09) is forindoor use.The restriction in indooruse can decrease the risklevel for the subjectdevice, thus ensure nonew safety andeffectiveness concernsraised due to thedifference. |
| Motor | Chongqing Mao TianMachinery Co., Ltd.,Brushless DC motor$180 W×24 VDCx2 pcs$ | Chongqing Mao TianMachinery Co., Ltd.,Brushless DC motor$250W x 24 VDC x 2 pcs$ | Similar motors are madeby the same company.Our motor power islarger than predicatedevice, and this meansmore driving force aresupplied to the subjectdevice, no safety andeffectiveness concernsraised. |
| Battery | Jiangsu Feng Chi GreenPower Supply Co., Ltd.,Lithium-ion$10Ahx24 VDCx2 pcs$ | Jiangsu Feng Chi GreenPower Supply Co., Ltd.,Lithium-ion, ITP2406$6 Ah x 24 VDC x 2 pcs$ | Similar batteries aremade by the samemanufacturer.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 nonew safety andeffectiveness concernsraised. | ||
|---|---|---|---|
| Charger model &rating | High Power TechnologyInc.HP1202BInput: AC100-240VOutput: DC 24V, 2Amp | High Power TechnologyInc.HP0060W(L2)Input: 100-240 VACOutput: DC 24V, 2 Amp | Similar chargers aremade by the samemanufacturer. Ourcharger meets ISO7176-25:2013, and nonew safety andeffectiveness concernsraised. |
| Number of Wheels | 4 | 4 | Same number of wheels |
| Driving system | Direct drive on the rearwheels | Direct drive on the rearwheels | Same driving system |
| Brake System | Smart Electromagneticbrake | Smart Electromagneticbrake | Same brake system |
| Max Speed(Forwards) | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same maximum speed,forward |
| Speed controlmethod | Joystick control method | Joystick control method | Same speed controlmethod |
| Main framematerial | 6063 aluminum alloy | 6063 aluminum alloy | Same frame material |
| Differences | |||
| Use environments | Indoor and outdoor use | Indoor use | Restricted use in theindoor environment willensure 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 frontwheels bring steadierpivoting function thanpredicate 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 rearwheels bring morecomfortable ride feelingthan predicate device. |
| Maximum safeoperational incline | 12 degrees | 8 degrees | We restrict the useenvironment for thesubject device to beindoor. 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 forthe DYW30A(D09) isenough for indoor use.No new safety andeffectiveness concernsare raised by thisdifference.Minor differences in thedimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
| Weight, w/ Battery | 60.87 lbs. / 27.6 kg | 51.8" lbs. / 23.5 kg | Less weight will lead tomore convenience whentransported and there ismore cruising range thanpredicate device. |
| Cruising Range | 9.3 miles (15 km) | 11.2 miles (18 km) | This difference is due tothe less weight and morepower for the subjectdevice, based on thework and energytheorem. There is alarger cruising range forthe subject device. |
| Max Loading | 250 lbs. | 264 lbs. | More loading weightmeans more convenientfor the transportation. |
| Max SpeedBackward | 2.4 mph (3.84 km/h) | 1.86 mph (3.0 km/h) | Smaller backward speedmeans lower risk levelfor the subject device. |
| Turning Radius | 31.5" (800 mm) | 32.5" (833 mm) | The minor difference inthe turning radius willcause someinconvenience when itturns in a narrow spaceand the difference willnot raise any new safetyand effectivenessconcerns |
| Maximum obstacleclimbing | 1.2" (30 mm) | 1.36" (34.5 mm) | The larger height in theobstacle climbing willnot impact the safetyand effectiveness of thesubject device. |
| Controller | Brushless dual-drive rockercontroller | Changzhou BillonElectronic Appliance Co.,Ltd., WS-1 | Our controller passedISO 7176-14 and thereis no safety andeffectiveness concernsraised due to thisdifference. |
| Minimum brakingdistance | 1.5 m | 1 m | Our minimum brakingdistance is smaller thanthe predicate device andthis ensures more safety.There is no new safetyand effectivenessconcerns raised due tothe 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}------------------------------------------------
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
{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
{11}------------------------------------------------
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
§ 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).