(1002 days)
Not Found
No
The device description and performance studies focus on standard powered wheelchair components and safety/performance testing, with no mention of AI/ML capabilities or related data/training sets.
No
The device is described as a transportation vehicle to provide mobility, not to treat or cure a medical condition.
No
The device description indicates that the e-Throne Folding Wheelchair is a transportation vehicle designed to provide mobility. It does not mention any function for diagnosing medical conditions or diseases.
No
The device description clearly outlines numerous hardware components including a frame, wheels, motors, batteries, and a control panel (joystick). While it mentions software verification testing, the device is fundamentally a physical powered wheelchair.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use: The intended use of the e-Throne Folding Wheelchair is clearly stated as providing mobility to a disabled or elderly person. It is a transportation vehicle.
- Device Description: The description details the mechanical and electrical components of a wheelchair. There is no mention of collecting or analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information related to diagnostic testing, sample handling, reagents, or analytical performance metrics typically associated with IVDs.
The e-Throne Folding Wheelchair is a mobility aid, not a diagnostic device.
N/A
Intended Use / Indications for Use
The e-Throne Folding Wheelchair, Model: ET-12F22 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The e-Throne Folding Wheelchair, Model: ET-12F22 is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users.
The e-Throne Folding Wheelchair consists of two foldable armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, a single Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by one Li-ion battery pack (24V, 15 Ah), which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
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
disabled people with mobility difficulties and elderly people
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)
The device has been evaluated for safety and performance by lab bench testing or other non-clinical way.
Risk Management was implemented in accordance with ISO 14971:2007.
Biocompatibility evaluation was carried out in accordance with IS0 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
Electrical Safety Testing was conducted in accordance with IEC 60601-1:2005 (3rd Edition).
Electromagnetic Compatibility Testing was conducted in accordance with IEC 60601-1-2:2014 and ISO 7176-21:2009.
Li-ion battery pack testing was conducted in accordance with IEC 62133-2:2017.
Performance Testing was conducted in accordance with numerous ISO 7176 standards (ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 7176-25).
Software verification testing was conducted as recommended by the FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
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.
Not Found
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
§ 890.3860 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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
January 21, 2022
Golden Motor Technology Co., Ltd. % Raymond Luo Regulation Manager Shanghai Sungo Management Consulting Company Limited 13F, Eastern Mansion, No.1500 Century Ave. Pudong New Area, Shanghai, 200120, China
Re: K191105
Trade/Device Name: e-Throne Folding Wheelchair, Model: ET-12F22 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 17, 2021 Received: December 27, 2021
Dear Raymond Luo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191105
Device Name
e-Throne Folding Wheelchair, Model: ET-12F22
Indications for Use (Describe)
The e-Throne Folding Wheelchair, Model : ET-12F22 is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K191105
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summarv prepared: 2022-01-21
2. Submitter's Information
Company Name: Golden Motor Technology Co., Ltd.
Address: Room 1401-1405, Tower 5, No.18-50 Middle Chang Wu Road, Changzhou 213164 Jiangsu, China
Phone: +86 519 81004118
Contact Person: Philip Yao
E-mail: sales@goldenmotor.com
Application Correspondent: Shanghai Sungo Management Consulting Company Limited
Address:13F, Eastern Mansion, No.1500 Century Ave., Pudong New Area, Shanghai
Contact Person: Raymond Luo Tile: Regulation Manager Tel:0086-21-68828050 Email: fda.sungo@@gmail.com
3. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Powered wheelchair Trade Name: e-Throne Folding Wheelchair, Model: ET-12F22 Classification Name: wheelchair, powered Review Panel: Physical Medicine Product Code: ITI Regulation Number:890.3860 Regulation Class: 2
| Sponsor | SUZHOU KD Medical Appliance Co. Ltd. |
|---|---|
| Device Name | PL001 power wheelchair |
| 510(k) Number | K113463 |
| Product Code | ITI |
| Regulation Number | 890.3860 |
| Regulation Class | 2 |
4. Predicate Device Information
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5. Device Description
The e-Throne Folding Wheelchair, Model: ET-12F22 is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users.
The e-Throne Folding Wheelchair consists of two foldable armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, a single Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by one Li-ion battery pack (24V, 15 Ah), which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
6. Intended Use / Indications for Use
The e-Throne Folding Wheelchair, Model: ET-12F22 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.
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| Attribute | Subject device | Predicate device | Discussion/
Conclusion |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Golden Motor Technology Co., Ltd. | SUZHOU KD Medical Appliance Co. Ltd. | / |
| Proprietary name, model | e-Throne Folding Wheelchair, Model:
ET-12F22 | PL001 power wheelchair | / |
| 510(k) number | K191105 | K113463 | / |
| Device classification name | Class II | Class II | Same |
| Classification regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Similarities | | | |
| Indication for use | The e-Throne Folding Wheelchair, Model :
ET-12F22 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, indoor and
outdoor transportation vehicle with the
intended use to provide mobility to a
disabled or elderly person limited to a seated
position. | Same |
| Intended user | disabled people with mobility difficulties and
elderly people | disabled or elderly person limited to a seated
position | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear
wheels | 4, including two pivoting casters and two
rear drive wheels | Same |
| Function of wheels | Front wheels: driven wheels suitable for
rotation, acceleration, retrograde
Rear wheels: driving wheels to control the speed | two pivoting casters: driven wheels suitable
for rotation, acceleration, retrograde
two rear drive wheels: driving wheels to | Same |
| Attribute | Subject device | Predicate device | Discussion/
Conclusion |
| | and direction | control the speed and direction | |
| Frame design | the frame of the wheelchair is type of aluminum
frame with front and rear folding structure;
Up-and-down turnable handrail, front and rear
adjustable armrest. | the frame of the wheelchair is type of
aluminum frame with front and rear folding
structure; Up-and-down turnable handrail,
front and rear adjustable armrest. | Same |
| Folding mechanism | The wheelchair can be folded to close the back
and seat parts face to face after push the two red
lock buttons to the central position.
fold the back and the armrest is rotated to the
down direction, and then close the back and seat
face to face, close the feet pedal as well. The
folding is completed. | the wheelchair can be folded to close the
back and seat parts face to face after push
the two lock buttons to the central position.
fold the back and the armrest is rotated to
the down direction, and then close the back
and seat face to face, close the feet pedal as
well. The folding is completed | Same |
| Max speed forward | 6 km/h, continuously adjustable | not publicly available | / |
| Maximum safe operational
incline degree | 9 ° | not publicly available | / |
| Movement control method | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rear wheels | not publicly available | / |
| Brake system | Automatic intelligent electromagnetic brake
system | not publicly available | / |
| Electronic controller | Brushless dual-drive rocker controller | not publicly available | / |
| Main frame material | Aluminum alloy | not publicly available | / |
| Armrest | PU | not publicly available | / |
| Seat cushion/back cushion | Nylon (Lining: PU foam) | not publicly available | / |
| Attribute | | | |
| Subject device | Predicate device | Discussion/Conclusion | |
| Differences | | | |
| Front wheel size/type | 8" x 2"/PU Solid tire | not publicly available | / |
| Rear wheel size/type | 12.5"x 2.4"/PU Solid tire | not publicly available | / |
| Max Speed backward | 0.8m/s (2.88km/h) | not publicly available | / |
| Max loading weight | 100 kg (220 lbs) | not publicly available | / |
| Battery charger | Off-board charger
Input: 100-240V, 50/60Hz,
Output: DC 24, 2A; | Off-board, Automatic Type
Input: 110-220 V / 50-60 Hz,
Output: 24 Vdc, 2A; | More wide range of input voltage in the
device which will not cause new safety
and effectiveness concerns raised. |
| Motor | brushless motor; 24VDC; 250W; 2pcs | not publicly available | / |
| Minimum braking distance
from maximum speed | Forward: 0.75 m | not publicly available | / |
| Battery | Li-ion; rechargeable, 24 VDC 15Ah | Li-ion, Rechargeable; 12 VDC 10Ah | same battery type, different power will
not affect the effectiveness and safety
of the device as both batteries are in
conformity with IEC 62133-2. |
| Maximum distance of travel
on the fully charged battery | 22 km | 20 km | longer distance of travel on the subject
device |
| Turning Radius | 650 mm | not publicly available | / |
| Maximum obstacle climbing | 50 mm | not publicly available | / |
7. Comparison of technological characteristics with the predicate device
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8. Summary of substantial equivalence discussion
The e-Throne Folding Wheelchair, Model: ET-12F22 complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2001, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1:2005+A1:2012, IEC 60601-1-2: 2014, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.
The intended uses for both devices are the same. Mainframes of two devices are folded by the same way as well. The design principles of the controller and driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Maximum obstacle climbing are different from each other while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2:2001. The biocompatibility of the predicate device and subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010.
The flame retardant test of the seat cushion/back cushion and armrest of both subject device and predicate device is carried out according to the ISO 7176-16 test. Therefore, both devices are assured to be under the same safety level.
In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
9. Summary of non-clinical testing (Performance testing-bench)
The device has been evaluated the safety and performance by lab bench testing or other non-clinical way as follows:
Risk Management
Risk analysis and management was implemented in accordance with ISO 14971:2007.
Biocompatibility
The biocompatibility evaluation for the e-Throne Folding Wheelchair, Model: ET-12F22 was carried out in accordance with 1S0 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
page 6 of 8
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Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety Testing was conducted on the e-Throne Folding Wheelchair, Model: ET-12F22 in accordance with IEC 60601-1:2005 (3rd Edition).
Electromagnetic Compatibility Testing was conducted on the e-Throne Folding Wheelchair, Model: ET-12F22 in accordance with IEC 60601-1-2:2014 and ISO 7176-21:2009.
Li-ion battery pack used on the e-Throne Folding Wheelchair, Model: ET-12F22 was conducted in accordance with IEC 62133-2:2017.
Performance Testing
Performance Testing was conducted on the e-Throne Folding Wheelchair, Model: ET-12F22 in accordance with the following standards:
- ISO 7176-1: 2014 Wheelchairs Part 1: Determination of static stability .
- . ISO 7176-2: 2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3: 2012 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: 2018 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 7176-25: 2013 Wheelchairs Batteries and chargers for powered wheelchairs ● page 7 of 8
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Software Verification and Validation Testing
Software Verification Testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following: Software verification testing was conducted on the subject device as recommended by the FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Level of Concern: The software for this device was considered as a moderate hazard.
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
10. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of e-Throne Folding Wheelchair, Model: ET-12F22 is substantially equivalent to the predicate devices quoted above. The differences between the subject device and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device e-Throne Folding Wheelchair, Model: ET-12F22 is substantially equivalent to the legally marketed predicate device.