Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and electrical components and standard safety/performance testing, with no mention of AI or ML capabilities.

Therapeutic

Yes
The "Intended Use / Indications for Use" states that the device is "intended for medical purposes to provide mobility to persons restricted to a sitting position," which identifies it as a therapeutic device.

Diagnostic

No

This device is a powered mobility scooter used to assist individuals with mobility, not to diagnose a condition. Its function is to provide physical support and transport.

SaMD (Software as a Medical Device)

No

The device description explicitly lists numerous hardware components such as a battery, frame, wheels, brakes, and a motor, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The Powered Mobility Scooter is designed to provide physical mobility to individuals who have difficulty walking. It is a mechanical device that assists with movement.
Intended Use: The intended use clearly states it's for "medical purposes to provide mobility to persons restricted to a sitting position." This is a functional aid, not a diagnostic tool.
Device Description: The description details mechanical components, battery power, and controls for movement. There is no mention of analyzing biological samples.
Lack of IVD Characteristics: The document lacks any information related to sample collection, analysis of biological markers, or diagnostic results, which are hallmarks of IVDs.

Therefore, based on the provided information, the Powered Mobility Scooter is a mobility aid and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Powered Mobility Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Product codes

INI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation
ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability
ISO 7176-2:2017, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs
ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5. Second edition 2008-06-01. Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space
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
ISO 7176-8:2014, Wheelchairs -Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered 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, First edition 1989-08-01, 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
ISO16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020 (including clause 8.11), plus immunity testing to 5G cellular signals.

No clinical study is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K220227

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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"

1

(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).

2

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

3

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K232692

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

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.

5

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

6

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.

7

Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China

H. Comparison with predicate Device

Table 1 General Comparison

| Elements of
Comparison | Predicate Device
(K220227) | Subject Device | Results |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Heartway Medical
Products Co., Ltd. | Intradin (Shanghai) Machinery
Co., Ltd | / |
| Common or
Usual name | Auto Folding Scooter,
S21F | Scooter | / |
| Model(s) | S21F | PMS101, GUT112, PMS
103, GUT140 | / |
| 510(k) number | K220227 | K232692 | / |
| Device
classification
name | Class II | Class II | Same |
| Classification
regulations | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Indications
for use | The device is intended for
medical purposes to
provide mobility to
persons restricted to a
sitting position. | The device is intended for
medical purposes to
provide mobility to
persons restricted to a
sitting position. | Same |
| Number of
wheels | 4 | 3 | Similar |
| Overall
Dimensions
(LengthWidth
Height) | 840mm x 460mm x
770mm | Model PMS101 & GUT112:
1025mm x 595mm x 940mm
Model PMS103 & GUT140:
1080mm x 600mm x 420mm | Similar
Analysis: The predicate device
and subject device have
different dimensions.
Both comply with ISO
7176-5:2008 Wheelchairs - Part
5: Determination of dimensions,
mass, and maneuverings space so
these differences do not
affect safety and effectiveness |
| Folded
Dimensions
(LengthWidth
Height) | 730mm x 440mm x
420mm | Model PMS101 & GUT112:
640mm x 595mm x 405mm
Model PMS103 & GUT140:
670mm x 600mm x 490mm | |
| Front wheel
size | 7" x 1.6"
(178 x41 mm) | Model PMS101 & GUT112:
170 x 45 mm
Model PMS103 & GUT140:
195x 50 mm | Similar,
Analysis: Different sizes of
wheel will not affect
safety and performance of the
subject device as all
related stability tests are
performed according to
standard ISO 7176 series. |
| Rear wheel size | 8" x 2"
(203x 51mm) | Model PMS101 & GUT112:
170 x 45 mm
Model PMS103 & GUT140: | |
| No. 118, Duhui Road, Minhang District, Shanghai, China | | | |
| | | 200 x 50 mm | |
| Maximum load | 115kg | 125kg | Similar,
Analysis:
Minor difference on Maximum
load will not cause different
performance. All safety and
performance have been validated
with the maximum rated weight
dummy. |
| Maximum
speed (forward) | 6km/h | 5.0km/h | Analysis
Minor difference on max.
forwarding speed will not cause
different performance. Lower
speed will be more safety |
| Battery | One 25.2 Vdc, 11.5 Ah
Lithium-ion Battery | 44.4V 2.0 Ah
Lithium-ion Battery | Similar,
Analysis:
The subject device complies with
ISO 7176- 25: 2013 Wheelchairs
Part 25: Batteries and chargers for
powered wheelchairs and EMC
testing, these differences do not
affect safety and effectiveness. |
| Charger | AC input.110-240 v,
50/60Hz, 84w
Output29.05V,2.5A | Input: AC 100-240V, 50/60Hz,
3A.
Output: 50.4V, 1A | |
| Travel distance | 15 km | Model PMS101&GUT112:
15.6km
Model PMS103 & GUT140:
10.4 km | Analysis:
The subject device
complies with ISO 7176- 4:
2008 Wheelchairs -
Part 4: Energy
consumption of electric
wheelchairs and scooters for
determination of
theoretical distance range, these
differences do not
affect safety and
effectiveness. |
| Type of
controller | Dynamic, R series,
DR50 | Brushless DC Motor Controller
Nominal Battery Voltage: 48V
Current Limit: 18±1A | Analysis :
Subject device control
system has passed the
requirements of ISO 7176-
14:2008 and
software validation, its
performance is surely
validated. The differences of
the electronic
controller's naming by the
predicate and subject devices
will not raise any new safety and
effectiveness concerns for the
subject device |
| Motor | 2.5 A max, 24 Vdc, 180 W | 48 volt DC, Brushless
electric motor with 3 phases
& sensors | |
| Scooter Weight
with 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 so
these differences do not affect
safety and effectiveness |
| | | Model PMS101 & GUT112:
1500mm
Model PMS103 & GUT140:
1550 mm | Analysis:
Larger turning radius will bring
more convenience
for the use environment.
All relevant tests have
been performed according to
standards ISO 7176
series, the difference will not
raise any new safety
and effectiveness
concerns. |
| Dynamic
Stabilities | 3° | Model PMS101 & GUT112:
3°
Model PMS103 & GUT140:
5° | Model PMS101 &GUT112:
Same
Model PMS103 &GUT140:
Analysis:
Greater dynamic stability usually
means that the vehicle is safer and
more reliable while
driving.Subject device control
system has passed the
requirements of ISO 7176-2
and test results meet its design
specification. |
| 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 has
passed the requirements of ISO
7176-1 and test results meet its
design specification. |
| Ground
clearance | 30 mm | Model PMS101 & GUT112:
67mm
Model PMS103 & GUT140:
82mm | Analysis:
The predicate device and
subject device have
different ground clearance.
Both comply with ISO
7176-5:2008 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 Climbing
Ability (max) | 15mm | Forward:
Model PMS101 & GUT112:
20mm
Model PMS 103 & GUT140:
25 mm
Reverse: 5mm | The subject device
complies with the
requirements of ISO
7176-10. |
| Braking distance
from max speed | N/A | Forward : 0.5m
Reverse:
Model PMS101&GUT112:
0.3m
Model PMS103 &GUT140:
0.2m | The subject device
complies with the
requirements of ISO
7176-3 |

8

Intradin (Shanghai) Machinery Co., Ltd
No. 118, Duhui Road, Minhang District, Shanghai, China

9

Intradin (Shanghai) Machinery Co., Ltd
No. 118, Duhui Road, Minhang District, Shanghai, China

10

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 contacting
materials are compliance with
ISO10993-5 and ISO10993-10
requirements.	All user directly contacting
materials are compliance with
ISO10993-5 ,ISO10993-10
and ISO10993-23
requirements.	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 | Result
s |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| ISO 7176-1 | The Static stability has been
determined after the testing according
to the ISO 7176-1, and test results
meet its design specification. | The Static stability has been
determined after the testing according
to the ISO 7176-1, and test results
meet its design specification. | SE |
| ISO 7176-2 | The dynamic stability has been
determined
after the testing according to the ISO
7176-2, and test results meet its
design specification. | The dynamic stability has been
determined
after the testing according to the ISO
7176-2, and test results meet its design
specification. | SE |
| ISO 7176-3 | The effectiveness of brakes has been | The effectiveness of brakes has been | SE |
| | determined after the testing
according to the ISO 7176-3, and
test results meet its design
specification. | determined after the testing
according to the ISO 7176-3, and test
results meet its design specification. | |
| ISO 7176-4 | The theoretical distance range
has been determined after the
testing according to the ISO
7176-4, and test results meet its
design specification. | The theoretical distance range
has been determined after the
testing according to the ISO
7176-4, and test results meet its
design specification. | SE |
| ISO 7176-5 | The dimensions, mass has been
determined after the testing
according to the ISO 7176- 5, | The dimensions, mass has been
determined after the testing
according to the ISO 7176- 5, | SE |
| ISO 7176-6 | The dimensions, mass has been
determined after the testing
according to the ISO 7176- 6, | The dimensions, mass has been
determined after the testing
according to the ISO 7176- 6, | SE |
| ISO 7176-7 | The seating and wheel dimensions
has
been determined after the testing
according to the ISO 7176-7, | The seating and wheel dimensions
has been determined after the testing
according to
the ISO 7176-7, | SE |
| ISO 7176-8 | All test results meet the
requirements in Clause 4 of
ISO 7176-8 | All test results meet the
requirements in Clause 4 of ISO
7176-8 | SE |
| ISO 7176-9 | The test results shown that the device
under tests could continue to function
according to manufacturer's
specification after being
subjected to each of the tests
specified in Clause 8 of ISO
7176-9 | The test results shown that the
device under tests could continue to
function according to
manufacturer's specification after
being subjected to each of the tests
specified in
Clause 8 of ISO 7176-9 | SE |
| ISO 7176-10 | The obstacle-climbing ability
of device has been determined
after the testing
according to the ISO 7176-10, | The obstacle-climbing ability of
device has been determined
after the testing
according to the ISO 7176-10, | SE |
| ISO 7176-11 | The test dummies used in the
testing of ISO 7176 series are meet
the requirements of
ISO 7176-11 | The test dummies used in the testing
of ISO 7176 series are meet the
requirements of
ISO 7176-11 | SE |
| ISO 7176-13 | The coefficient of friction of test
surfaces has
been determined, which could be
used in other 7176 series tests
involved | The coefficient of friction of test
surfaces has
been determined, which could be
used in other 7176 series tests
involved | SE |
| ISO 7176-14 | All test results meet the
requirements in Clause 7, 8, 9,
10, 11, 12, 13, 14, 15, 17 of
ISO 7176-14 | All test results meet the
requirements in Clause 7, 8, 9,
10, 11, 12, 13, 14, 15, 17 of ISO
7176-14 | SE |
| | The test results shown that
information | The test results shown that information | |
| ISO 7176-15 | disclosure, documentation and
labelling of device meet the
requirements of ISO
7176-15 | disclosure, documentation and
labelling of device meet the
requirements of ISO
7176-15 | SE |
| ISO 16840-10 | The performance of resistance to
ignition meet the requirements of
ISO16840-10. | The performance of resistance to
ignition meet the requirements of
ISO 7176-16 | SE |
| ISO 7176-21 | The EMC performance results
meet the requirements of ISO
7176-21 | The EMC performance results
meet the requirements of ISO
7176-21 | SE |
| ISO 7176-25 | The performance of batteries and
charger of device meet the
Requirements in Clause 5
and 6 of ISO 7176-25 | The performance of batteries and
charger of device meet the
Requirements in Clause 5
and 6 of ISO 7176-25 | SE |

11

Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District, Shanghai, China

12

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.