(366 days)
The Powered Mobility Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Powered Mobility Scooter. Models: PMS101. GUT112, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor .It has a driving range of 15.6 km between charges. It is capable of carrying a driver weighing up to 125 kg.
The Powered Mobility Scooter, Models: PMS103, GUT140, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, Armrest, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor. It has a driving range of 10.4 km between charges. It is capable of carrying a driver weighing up to 125 kg.
The provided text is an FDA 510(k) summary for a Powered Mobility Scooter. It outlines the safety and performance testing conducted for the device to demonstrate its substantial equivalence to a predicate device. However, this document does not describe a study that uses AI or machine learning, involves diagnostic imaging, or establishes ground truth through expert consensus, pathology, or outcomes data in the way a medical AI device submission would.
Therefore, many of the requested criteria (e.g., sample size for test set, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it pertains to a physical medical device (a mobility scooter) and traditional engineering and biocompatibility testing, not an AI/ML medical device.
Based on the provided text, here is the information that can be extracted, with explanations for why certain criteria cannot be met:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for this device are compliance with a comprehensive set of ISO standards related to wheelchairs and scooters, along with biocompatibility testing and EMC. The "reported device performance" is the demonstration that the subject device meets the requirements of these standards and is substantially equivalent to the predicate device. The tables provided in the document (Table 1, 2, and 3) show comparisons between the subject device and the predicate device across various parameters and confirm compliance with relevant ISO standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Compliance / Result) |
|---|---|
| Biocompatibility | |
| ISO 10993-5: 2009 (Cytotoxicity) | Compliant for all user-directly contacting materials |
| ISO 10993-10: 2021 (Skin Sensitization) | Compliant for all user-directly contacting materials |
| ISO 10993-23: 2021 (Irritation) | Compliant for all user-directly contacting materials |
| Electromagnetic Compatibility (EMC) | |
| ISO 7176-21: 2009 | Compliant (Performance results meet requirements) |
| IEC 60601-1-2: 2020 (including 8.11) | Compliant |
| Immunity to 5G cellular signals | Compliant |
| Mechanical & Performance Standards (ISO 7176 Series) | |
| ISO 7176-1: 2014 (Static Stability) | Test results meet design specification (Tipping Angles reported for PMS101/GUT112 and PMS103/GUT140) |
| ISO 7176-2: 2017 (Dynamic Stability) | Test results meet design specification (3° for PMS101/GUT112, 5° for PMS103/GUT140) |
| ISO 7176-3: 2012 (Effectiveness of Brakes) | Test results meet design specification (Braking distance from max speed: 0.5m forward, 0.3m/0.2m reverse) |
| ISO 7176-4: 2008 (Theoretical Distance Range) | Test results meet design specification (15.6km for PMS101/GUT112, 10.4km for PMS103/GUT140) |
| ISO 7176-5: 2008 (Dimensions, Mass, Maneuvering) | Test results meet design specification (Overall and Folded Dimensions, Weight reported) |
| ISO 7176-6: 2018 (Max Speed, Acceleration, Deceleration) | Test results meet design specification (Max speed: 5.0 km/h) |
| ISO 7176-7 (Seating & Wheel Dimensions) | Test results meet design specification (Wheel sizes reported) |
| ISO 7176-8: 2014 (Static, Impact, Fatigue Strengths) | All test results meet requirements in Clause 4 |
| ISO 7176-9: 2009 (Climatic Tests) | Device continued to function according to manufacturer's spec after tests |
| ISO 7176-10: 2008 (Obstacle-Climbing Ability) | Test results meet design specification (20mm/25mm forward, 5mm reverse) |
| ISO 7176-11: 2012 (Test Dummies) | Test dummies used met requirements |
| ISO 7176-13: 1989 (Coefficient of Friction of Test Surfaces) | Determined and used in other 7176 tests |
| ISO 7176-14: 2008 (Power & Control Systems) | All test results meet requirements in Clauses 7-15, 17 |
| ISO 7176-15: 1996 (Information Disclosure, Documentation, Labeling) | Test results meet requirements |
| ISO 16840-10: 2021 (Resistance to Ignition) | Performance meets requirements |
| ISO 7176-25: 2013 (Batteries & Chargers) | Performance meets requirements in Clauses 5 and 6 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: This document does not specify a "sample size" in terms of cases or subjects in the way an AI/ML study would. Instead, it refers to non-clinical laboratory testing performed on the physical device itself (the Powered Mobility Scooter models PMS101, GUT112, PMS103, GUT140). The testing involves subjecting units of the device to various mechanical, electrical, and biocompatibility tests according to the listed ISO standards. The "sample" is implicitly the physical device units tested to demonstrate compliance.
- Data Provenance: The testing was conducted by Intradin (Shanghai) Machinery Co., Ltd located in Shanghai, China. The data provenance is from non-clinical laboratory tests performed on manufactured units of the device, not from retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML or diagnostic imaging device. "Ground truth" in this context refers to engineering specifications and compliance with established international standards for mobility devices, which are validated through physical testing, not expert interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is not an AI/ML or diagnostic imaging device involving human reviewers or adjudication. Test results are objective measurements against defined 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:
- No. This is not an AI-assisted device for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical mobility device, not a standalone algorithm.
7. The type of ground truth used:
- Engineering Standards and Specifications: The "ground truth" for this device's performance is adherence to defined parameters within the listed international ISO standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, IEC 60601-1-2 for EMC). Compliance is determined by whether the device's measured performance falls within the acceptable ranges or meets the criteria specified by these widely accepted engineering and safety standards.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 5, 2024
Intradin (Shanghai) Machinery Co., Ltd % Ariel Xiang Senior Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K232692
Trade/Device Name: Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 9, 2024 Received: August 9, 2024
Dear Ariel Xiang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
Indications for Use (Describe)
The Powered Mobility Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China 510(K) Summary K232692
Document Prepared Date: 2024/09/03
Applicant: A.
Intradin (Shanghai) Machinery Co., Ltd
Address: No. 118, Duhui Road, Minhang District, Shanghai, China
Contact Person: Mark Li
Tel: + 86 021-64908190-6665
Submission Correspondent:
Primary contact: Ms. Ariel Xiang
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802
Email: jiawei.wu@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050
Email: zxfda(@sungoglobal.com
B. Device:
Trade Name: Powered Mobility Scooter Common Name: Scooter
Models: PMS101, GUT112, PMS103, GUT140
Regulatory Information
Classification Name: Motorized three-wheeled vehicle Classification: Class II.
Product code: INI
Regulation Number: 890.3800
Review Panel: Physical Medicine
C. Predicate device:
510Knumber: K220227
Device Name: Auto Folding Scooter, S21F
Manufacturer: Heartway Medical Products Co., Ltd.
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Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China
D. Indications for use of the device:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
E. Device Description:
The Powered Mobility Scooter. Models: PMS101. GUT112, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, One Front wheel and Two Rear wheels.
The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor .It has a driving range of 15.6 km between charges. It is capable of carrying a driver weighing up to 125 kg.
Note: The Powered Mobility Scooter, Model PMS101 and GUT112 are identical devices, two different model numbers are for sale purpose.
The Powered Mobility Scooter, Models: PMS103, GUT140, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, Armrest, One Front wheel and Two Rear wheels.
The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor. It has a driving range of 10.4 km between charges. It is capable of carrying a driver weighing up to 125 kg.
Note: The Powered Mobility Scooter, Model PMS103 and GUT140 are identical devices, two different model numbers are for sale purpose.
The model PMS101/GUT112 and PMS103/GUT140 mobility scooter power control systems and related components(controller, motor, battery, charger) are identical.
Note: The dynamic stability rating of 3° applies to braking while traveling straight on an inclined surface.
WARNING - Do not use maximum speed while making turns, as the scooter is not stable under these conditions and may tip over, causing a risk injury.
F. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin ﺪ sensitization
- ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation A
- ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability A
- ISO 7176-2:2017, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs A
- ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness ofbrakes A
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Intradin (Shanghai) Machinery Co., Ltd
No. 118, Duhui Road, Minhang District, Shanghai, China
- ル ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption ofelectric wheelchairs and scooters for determination of theoretical distance range
- ﺮ ISO 7176-5. Second edition 2008-06-01. Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space
- ア ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
- ≫ ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- A ISO 7176-8:2014, Wheelchairs -Part 8: Requirements and test methods for static, impact and fatigue strengths
- 公 ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
- ﺮ ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ア ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
- ﺮ ISO 7176-13, First edition 1989-08-01, 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
- ﺮ ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- A ISO16840-10: 2021Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- ア ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- V ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- ア Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020 (including clause 8.11), plus immunity testing to 5G cellular signals.
G. Clinical Test Conclusion
No clinical study is included in this submission.
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Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China
H. Comparison with predicate Device
Table 1 General Comparison
| Elements ofComparison | Predicate Device(K220227) | Subject Device | Results |
|---|---|---|---|
| Manufacturer | Heartway MedicalProducts Co., Ltd. | Intradin (Shanghai) MachineryCo., Ltd | / |
| Common orUsual name | Auto Folding Scooter,S21F | Scooter | / |
| Model(s) | S21F | PMS101, GUT112, PMS103, GUT140 | / |
| 510(k) number | K220227 | K232692 | / |
| Deviceclassificationname | Class II | Class II | Same |
| Classificationregulations | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Indicationsfor use | The device is intended formedical purposes toprovide mobility topersons restricted to asitting position. | The device is intended formedical purposes toprovide mobility topersons restricted to asitting position. | Same |
| Number ofwheels | 4 | 3 | Similar |
| OverallDimensions(LengthWidthHeight) | 840mm x 460mm x770mm | Model PMS101 & GUT112:1025mm x 595mm x 940mmModel PMS103 & GUT140:1080mm x 600mm x 420mm | SimilarAnalysis: The predicate deviceand subject device havedifferent dimensions.Both comply with ISO7176-5:2008 Wheelchairs - Part5: Determination of dimensions,mass, and maneuverings space sothese differences do notaffect safety and effectiveness |
| FoldedDimensions(LengthWidthHeight) | 730mm x 440mm x420mm | Model PMS101 & GUT112:640mm x 595mm x 405mmModel PMS103 & GUT140:670mm x 600mm x 490mm | |
| Front wheelsize | 7" x 1.6"(178 x41 mm) | Model PMS101 & GUT112:170 x 45 mmModel PMS103 & GUT140:195x 50 mm | Similar,Analysis: Different sizes ofwheel will not affectsafety and performance of thesubject device as allrelated stability tests areperformed according tostandard ISO 7176 series. |
| Rear wheel size | 8" x 2"(203x 51mm) | Model PMS101 & GUT112:170 x 45 mmModel PMS103 & GUT140: | |
| No. 118, Duhui Road, Minhang District, Shanghai, China | |||
| 200 x 50 mm | |||
| Maximum load | 115kg | 125kg | Similar,Analysis:Minor difference on Maximumload will not cause differentperformance. All safety andperformance have been validatedwith the maximum rated weightdummy. |
| Maximumspeed (forward) | 6km/h | 5.0km/h | AnalysisMinor difference on max.forwarding speed will not causedifferent performance. Lowerspeed will be more safety |
| Battery | One 25.2 Vdc, 11.5 AhLithium-ion Battery | 44.4V 2.0 AhLithium-ion Battery | Similar,Analysis:The subject device complies withISO 7176- 25: 2013 WheelchairsPart 25: Batteries and chargers forpowered wheelchairs and EMCtesting, these differences do notaffect safety and effectiveness. |
| Charger | AC input.110-240 v,50/60Hz, 84wOutput29.05V,2.5A | Input: AC 100-240V, 50/60Hz,3A.Output: 50.4V, 1A | |
| Travel distance | 15 km | Model PMS101&GUT112:15.6kmModel PMS103 & GUT140:10.4 km | Analysis:The subject devicecomplies with ISO 7176- 4:2008 Wheelchairs -Part 4: Energyconsumption of electricwheelchairs and scooters fordetermination oftheoretical distance range, thesedifferences do notaffect safety andeffectiveness. |
| Type ofcontroller | Dynamic, R series,DR50 | Brushless DC Motor ControllerNominal Battery Voltage: 48VCurrent Limit: 18±1A | Analysis :Subject device controlsystem has passed therequirements of ISO 7176-14:2008 andsoftware validation, itsperformance is surelyvalidated. The differences ofthe electroniccontroller's naming by thepredicate and subject deviceswill not raise any new safety andeffectiveness concerns for thesubject device |
| Motor | 2.5 A max, 24 Vdc, 180 W | 48 volt DC, Brushlesselectric motor with 3 phases& sensors | |
| Scooter Weightwith Battery | 51.8 Ibs. (23.5 kg) | PMS101&GUT112:18kg | Analysis:The predicate device and subject |
| Turn radius | 1110mm | PMS103 &GUT140:24kg | device havedifferent weight..Both comply with ISO 7176-5:2008 Wheelchairs - Part 5:Determination of dimensions,mass, and maneuverings space sothese differences do not affectsafety and effectiveness |
| Model PMS101 & GUT112:1500mmModel PMS103 & GUT140:1550 mm | Analysis:Larger turning radius will bringmore conveniencefor the use environment.All relevant tests havebeen performed according tostandards ISO 7176series, the difference will notraise any new safetyand effectivenessconcerns. | ||
| DynamicStabilities | 3° | Model PMS101 & GUT112:3°Model PMS103 & GUT140:5° | Model PMS101 &GUT112:SameModel PMS103 &GUT140:Analysis:Greater dynamic stability usuallymeans that the vehicle is safer andmore reliable whiledriving.Subject device controlsystem has passed therequirements of ISO 7176-2and test results meet its designspecification. |
| Static Stabilities | 6° | Tipping Angles:Model PMS101 & GUT112:Uphill:Least stable configuration: 20.8°Most stable configuration: 22.0°Sideway: Left 11.8°, Right 12.2°Model PMS103 & GUT140:Uphill:Least table tipping angle: 18.8°,Most stable tipping angle: 20.4°Sideway: Left 13.1°, Right 12.8° | Analysis:Subject device control system haspassed the requirements of ISO7176-1 and test results meet itsdesign specification. |
| Groundclearance | 30 mm | Model PMS101 & GUT112:67mmModel PMS103 & GUT140:82mm | Analysis:The predicate device andsubject device havedifferent ground clearance.Both comply with ISO7176-5:2008 Wheelchairs - Part |
| No. 118, Dului Road, Minhang District, Shanghai, China | 5: Determination of dimensions, mass, and maneuverings space so these differences do not affect safety and effectiveness | ||
| Obstacle ClimbingAbility (max) | 15mm | Forward:Model PMS101 & GUT112:20mmModel PMS 103 & GUT140:25 mmReverse: 5mm | The subject devicecomplies with therequirements of ISO7176-10. |
| Braking distancefrom max speed | N/A | Forward : 0.5mReverse:Model PMS101&GUT112:0.3mModel PMS103 &GUT140:0.2m | The subject devicecomplies with therequirements of ISO7176-3 |
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Intradin (Shanghai) Machinery Co., Ltd
No. 118, Duhui Road, Minhang District, Shanghai, China
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Intradin (Shanghai) Machinery Co., Ltd
No. 118, Duhui Road, Minhang District, Shanghai, China
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Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China
Table 2 Safety comparison
| Item | Predicate Devices | Subject Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements. | All user directly contactingmaterials are compliance withISO10993-5 ,ISO10993-10and ISO10993-23requirements. | S.E. |
| EMC | ISO7176-21 | ISO7176-21& IEC 60601-1-2 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
Table 3 Safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| ISO 7176-1 | The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test resultsmeet its design specification. | The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test resultsmeet its design specification. | SE |
| ISO 7176-2 | The dynamic stability has beendeterminedafter the testing according to the ISO7176-2, and test results meet itsdesign specification. | The dynamic stability has beendeterminedafter the testing according to the ISO7176-2, and test results meet its designspecification. | SE |
| ISO 7176-3 | The effectiveness of brakes has been | The effectiveness of brakes has been | SE |
| determined after the testingaccording to the ISO 7176-3, andtest results meet its designspecification. | determined after the testingaccording to the ISO 7176-3, and testresults meet its design specification. | ||
| ISO 7176-4 | The theoretical distance rangehas been determined after thetesting according to the ISO7176-4, and test results meet itsdesign specification. | The theoretical distance rangehas been determined after thetesting according to the ISO7176-4, and test results meet itsdesign specification. | SE |
| ISO 7176-5 | The dimensions, mass has beendetermined after the testingaccording to the ISO 7176- 5, | The dimensions, mass has beendetermined after the testingaccording to the ISO 7176- 5, | SE |
| ISO 7176-6 | The dimensions, mass has beendetermined after the testingaccording to the ISO 7176- 6, | The dimensions, mass has beendetermined after the testingaccording to the ISO 7176- 6, | SE |
| ISO 7176-7 | The seating and wheel dimensionshasbeen determined after the testingaccording to the ISO 7176-7, | The seating and wheel dimensionshas been determined after the testingaccording tothe ISO 7176-7, | SE |
| ISO 7176-8 | All test results meet therequirements in Clause 4 ofISO 7176-8 | All test results meet therequirements in Clause 4 of ISO7176-8 | SE |
| ISO 7176-9 | The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after beingsubjected to each of the testsspecified in Clause 8 of ISO7176-9 | The test results shown that thedevice under tests could continue tofunction according tomanufacturer's specification afterbeing subjected to each of the testsspecified inClause 8 of ISO 7176-9 | SE |
| ISO 7176-10 | The obstacle-climbing abilityof device has been determinedafter the testingaccording to the ISO 7176-10, | The obstacle-climbing ability ofdevice has been determinedafter the testingaccording to the ISO 7176-10, | SE |
| ISO 7176-11 | The test dummies used in thetesting of ISO 7176 series are meetthe requirements ofISO 7176-11 | The test dummies used in the testingof ISO 7176 series are meet therequirements ofISO 7176-11 | SE |
| ISO 7176-13 | The coefficient of friction of testsurfaces hasbeen determined, which could beused in other 7176 series testsinvolved | The coefficient of friction of testsurfaces hasbeen determined, which could beused in other 7176 series testsinvolved | SE |
| ISO 7176-14 | All test results meet therequirements in Clause 7, 8, 9,10, 11, 12, 13, 14, 15, 17 ofISO 7176-14 | All test results meet therequirements in Clause 7, 8, 9,10, 11, 12, 13, 14, 15, 17 of ISO7176-14 | SE |
| The test results shown thatinformation | The test results shown that information | ||
| ISO 7176-15 | disclosure, documentation andlabelling of device meet therequirements of ISO7176-15 | disclosure, documentation andlabelling of device meet therequirements of ISO7176-15 | SE |
| ISO 16840-10 | The performance of resistance toignition meet the requirements ofISO16840-10. | The performance of resistance toignition meet the requirements ofISO 7176-16 | SE |
| ISO 7176-21 | The EMC performance resultsmeet the requirements of ISO7176-21 | The EMC performance resultsmeet the requirements of ISO7176-21 | SE |
| ISO 7176-25 | The performance of batteries andcharger of device meet theRequirements in Clause 5and 6 of ISO 7176-25 | The performance of batteries andcharger of device meet theRequirements in Clause 5and 6 of ISO 7176-25 | SE |
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Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China
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Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China
I. Substantial Equivalence Discussion
The proposed device and predicate device are complying to the same ISO 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 16840-10, ISO 7176-21, ISO 7176-25, and FDA guidance Submission for Scooter.
The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ control criteria following above mentioned standards. And the test results show that the subject product is substantially equivalent to the predicate device in performance.
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability (Scooter tipping angle), The Dynamic stability (Safe Gradient Maximum Gradient), Brake performance, Theoretical distance range, Dimension and weight, Maximum speed, Dimension of wheel Static, impact and fatigue strengths, Climatic tests, Obstacle-climbing ability, Dummy, friction of test surfaces, Power and control systems, Documentation and labeling, Resistance to ignition, Electromagnetic Compatibility and Electrical Safety, Batteries and chargers.
The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Powered Mobility Scooter, Models: PMS101, GUT112, PMS103, GUT140, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K220227.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).