(191 days)
The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that is powered by two 22Ah lead-acid batteries, equipped with four pneumatic wheels, capacity of 136 kilograms and a lightweight adjustable seat. It a rear wheel drive scooter with theoretical driving ranges of 17.5 kilometer. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an off-board battery charger.
Based on the provided document, the device in question is the "C.T.M. Mobility Scooter, HS-328." This document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter #HS-295), rather than proving that a new AI/algorithm-based device meets specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, study design, ground truth establishment, expert involvement, and statistical analyses for an AI/algorithm performance study (like an MRMC study or standalone algorithm performance) is not available in this document. The document explicitly states:
"This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." (Page 10)
The "studies" mentioned are non-clinical bench tests and compliance with recognized consensus standards (e.g., ISO, IEC) for performance, electrical safety, biocompatibility, and EMC. These tests are conducted to show that the physical characteristics and basic functionality of the mobility scooter are safe and perform as expected, and that any differences from the predicate device do not raise new questions of safety or effectiveness. They are not the type of AI/algorithm performance studies you've asked about.
Given this, I cannot fill out the requested table or provide details for points 2-9 as they pertain to a type of study not conducted or reported in this document.
However, I can extract the closest information to "acceptance criteria" and "reported device performance" as presented for the physical device, primarily through comparison to its predicate.
Table of Acceptance Criteria (as implied by comparison to predicate) and Reported Device Performance
For the C.T.M. Mobility Scooter HS-328, "acceptance criteria" are implied by its substantial equivalence to the predicate device (HS-295) and its compliance with relevant standards. The "reported device performance" is essentially the specifications of the new device and the assertion that differences from the predicate do not affect safety or effectiveness.
| Category | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (HS-328) |
|---|---|---|
| Primary Indication for Use | Same as Predicate: Indoor/outdoor transportation for a disabled or elderly person. | The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person. |
| Classification Name/Product Code | Same as Predicate: Motorized three-wheeled vehicle / INI. | Motorized three-wheeled vehicle / INI. |
| Safety (via Non-Clinical Tests & Standards) | Compliance with: - ISO10993-5 (Biocompatibility) - ISO10993-10 (Biocompatibility) - IEC60601-1 (Electrical safety) - IEC60601-1-2 (EMC) - IEC62304 (Software, by controller) - ISO7176 series (various performance & safety aspects) - Crucially, differences vs. predicate must not affect safety. | All safety tests performed and meet requirements of listed FDA Recognized Consensus Standards. "All the differences don't affect the safety and performance after verified by safety and performance test." |
| Performance (via Non-Clinical Tests & Standards) | Compliance with ISO7176 series standards for: - Static/dynamic stability - Brake effectiveness - Energy consumption/theoretical distance range - Dimensions, mass, maneuvering space - Maximum speed, acceleration, deceleration - Wheel dimensions - Static, impact, fatigue strengths - Climatic tests - Obstacle-climbing ability - Power/control systems - EMC | Bench tests performed in accordance with FDA Recognized Consensus Standards (ISO 7176 series). All tests passed requirements to demonstrate substantial equivalence. |
| Key Performance Parameters | General equivalence or improvement over predicate without creating new safety/effectiveness questions. (Specific numerical criteria aren't provided beyond comparison table) | Overall Length: 1120 mm / 44" (vs. 1013 mm / 39.8" for HS-295)Overall Width: 590 mm / 23.2" (vs. 509 mm / 19.9" for HS-295)Overall Height: 935 mm / 36.8" (vs. 887 mm / 34.9" for HS-295)Product weight (With battery): 55 kg / 121.3 lbs (vs. 49 kg / 109 lbs for HS-295)Weight Of Heaviest Piece: 17 kg / 37.5 lbs (vs. 17.8 kg / 39.2 lbs for HS-295)Braking distance: 1.3m/51.2" (vs. 1.7m/66.9" for HS-295)Front & Rear Wheels: 225 mm / 9" (vs. 200 mm / 8" for HS-295)Maximum distance of travel on fully charged battery: 17.5 km / 10.9 Miles (vs. 10 km / 6.2 Miles for HS-295)Ground Clearance: 52 mm / 2" (vs. 40 mm / 1.6" for HS-295)Curb Climbable: 40 mm / 1.6" (vs. 32.5 mm / 1.3" for HS-295)Turning Radius: 1450 mm / 57.1" (vs. 1270 mm / 50" for HS-295) |
| Technological Characteristics | Similar design features, rear-wheel drive, Electro-Mechanical brakes, dismantles for transport, Dynamic Rhino 50 controllers. Differences in motor size, capacity, and battery output must not affect safety/performance. | Has same 4 wheels, rear-wheel drive technology, Electro-Mechanical brakes, dismantles for transport. Uses Dynamic Rhino 50 controllers. Has a single motor and two batteries (22Ah). |
Regarding AI/Algorithm-Specific Study Information (Points 2-9):
As stated above and explicitly in the document, no clinical study was performed or utilized for this 510(k) submission to establish substantial equivalence. Therefore, the following points are not applicable to this document:
- Sample size used for the test set and data provenance: N/A (no such test set for AI/algorithm performance was used).
- Number of experts used to establish ground truth for the test set and qualifications: N/A.
- Adjudication method for the test set: N/A.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: N/A.
- Standalone (algorithm only without human-in-the-loop performance) study: N/A.
- Type of ground truth used: N/A (Ground truth, in the context of diagnostic AI, implies a reference standard for a clinical condition, which is not relevant for a mobility scooter).
- Sample size for the training set: N/A (no AI/ML training involved for this device submission).
- How the ground truth for the training set was established: N/A.
In summary, this document describes a traditional medical device (mobility scooter) cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, relying on non-clinical bench testing and compliance with recognized standards for safety and performance, rather than clinical studies or AI/algorithm performance evaluations.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
Chien Ti Enterprise Co., Ltd. Vivian Lo Sales Manager No. 13, Lane 227, Fu Ying Rd Hsin Chuang District, New Taipei City, Taiwan 24258
Re: K162952
Trade/Device Name: C.T.M. Mobility Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 21, 2017 Received: April 26, 2017
Dear Vivian Lo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K162952
Device Name C.T.M. Mobility Scooter
Indications for Use (Describe)
The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image is the logo for C.T.M. The logo is in the shape of an oval with a gray border. Inside the oval are the letters C.T.M. in red, with blue swooshes above and below the letters.
- Lane 227. Fu Ying Rd., Hsin Chuang District, New Taipei City, Taiwan Fax : +886-2-2904-1170 · 2903-88 +886-2-2903-2987 http://www.chienti.com.tw Mail : sales@chienti.com.tw
510(k) Summary
| Company Name: | CHIEN TI ENTERPRISE CO., LTD. |
|---|---|
| Company Address: | No. 13, Lane 227, Fu Ying Rd |
| New Taipei City, Hsin Chuang District,, 24258, TAIWAN (CHINA) | |
| Telephone: | +886-2-29032987 |
| Fax: | +886-2-29038807 |
| Contact Person: | Ms. Vivian Lo |
| Summary Preparation Date: | 2017.4.24 |
Device Name:
| Trade Name: | C.T.M. Mobility Scooter, HS-328 |
|---|---|
| Classification Name: | Motorized three-wheeled vehicle |
| Regulation Number: | 890.3800 |
| Product Code: | INI |
| Device Class: | Class 2 |
| Panel: | Physical Medicine |
PREDICATE DEVICE:
K070603, C.T.M. Mobility Scooter #HS-295
Indications for Use (IFU) statement:
The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Device Description
The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that is powered by two 22Ah lead-acid batteries, equipped with four pneumatic wheels, capacity of 136 kilograms and a lightweight adjustable seat. It a rear wheel drive scooter with theoretical driving ranges of 17.5 kilometer. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an off-board battery charger.
Substantial Equivalence Comparison
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for C.T.M. The logo is an oval shape with a gray border. Inside the oval is the text "C.T.M." in red, with a blue swoosh above and below the text. There is a registered trademark symbol next to the M.
The C.T.M. Mobility Scooter, HS-328 and the C.T.M. Mobility Scooter #HS-295 have same intended use and classification name/ product code.
The C.T.M. Mobility Scooter, HS-328 and the C.T.M. Mobility Scooter #HS-295 have similar design features. Regarding the HS-328, the dimensions is bigger and heaviler, but not significantly. Both scooters have same 4 wheels, rear-wheel drive technology, Electro-Mechanical brakes, Weight of Heaviest Piece, Dismantle for transport. The control systems are used for exact same model, Dynamic Rhino 50 controllers (DR50). The features on the tiller and controller are same. Each scooter has s single motor and two batteries. The differences are motor size, capacity and output of battery. All the differences don't affect the safety and performance after verified by safety and performance test. It is operated exactly the same way as HS-295 during riding and functions on similar ideology and theories.
The new HS-328 with its built in modern technologies for improvements in effectiveness and safety, in many comparable criterions, considered fairly similar to its predicate devices: HS-295. Furthermore, the new HS-328 has been also tested and certified by relevant required ANSI/RESNA. ISO, IEC standards which are included in this submission.
All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.
| Category | C.T.M. MobilityScooter, HS-328New device | C.T.M. MobilityScooter #HS-295K070603 | Result ofComparasion |
|---|---|---|---|
| Indications forUse (IFU)statement | The C.T.M. MobilityScooter HS-328 in anindoor/outdoor scooterthat providestransportation for adisabled or elderlyperson. | The C.T.M. MobilityScooter HS-295 is anindoor/outdoor scooterthat providestransportation for adisabled or elderlyperson. | Same |
| The genericname of the | Electric scooter | Electric scooter | Same |
| Category | C.T.M. MobilityScooter, HS-328New device | C.T.M. MobilityScooter #HS-295K070603 | Result ofComparasion |
| device | |||
| Classificationname | 890.3800 Motorized3-wheeled vehicle | 890.3800 Motorized3-wheeled vehicle | Same |
| Product Code | 89 INI | 89 INI | Same |
| Device Features | |||
| Overall Length | 1120 mm / 44" | 1013 mm / 39.8" | Different |
| Overall Width | 590 mm / 23.2" | 509 mm / 19.9" | Different |
| Overall Height | 935 mm / 36.8" | 887 mm / 34.9" | Different |
| Product weightWith battery | 55 kg / 121.3 lbs | 49 kg / 109 lbs | Different |
| Weight OfHeaviest Piece | 17 kg / 37.5 lbs | 17.8 kg / 39.2 lbs | Different |
| Color of Cover | Ice Blue, Burgundy andSilver | Burgundy 、Silver、Blue | Different |
| Dismantle fortransport? | Yes | Yes | Same |
| Drivetechnology | Rear-wheel drive | Rear-wheel drive | Same |
| Suspension | Rear (Option) | N/A | Different |
| Motors –NumberSize | 1250W, 4000 r.p.m | 1250W, 4600 r.p.m | Different |
| Brake | Electro-Mechanical | Electro-Mechanical | Same |
| Braking distance | 1.3m/51.2" | 1.7m/66.9" | Different |
| Wheels number | 4 | 4 | Same |
| Front Wheels | 225 mm / 9" | 200 mm / 8" | Different |
| Rear Wheels | 225 mm / 9" | 200 mm / 8" | Different |
| Wheelsmaterials | PU foaming casterRim Material: PA+GFTire Type: filling PUrubber | PU foaming casterRim Material: PA+GFTire Type: filling PUrubber | Same |
| Category | C.T.M. MobilityScooter, HS-328New device | C.T.M. MobilityScooter #HS-295K070603 | Result ofComparasion |
| Anti-tip wheels | Yes | Yes | Same |
| Controller | Dynamic Rhino 50 | Dynamic Rhino 50 | Same |
| Function of Control panel | |||
| On/offswitches | Yes | Yes | Same |
| Speed Hi/LoDial knob | Yes | Yes | Same |
| Battery gaugeindicator | Yes | Yes | Same |
| Self-DiagnosticWarning Lig | Yes | Yes | Same |
| Throttle | Yes | Yes | Same |
| Horn Button | Yes | Yes | Same |
| RearPosition light | Yes (optional accessary) | No | Different |
| Battery –Number | 2 | 2 | Different |
| Type | Rechargeable SealedLead-Acid12V/22Ah | Rechargeable SealedLead-Acid 12V/12Ah | |
| Sizeweight | 15.5 kg / 34.2 lbs | 10.4 kg / 23 lbs | |
| Battery charger | Different | ||
| Availability | Off-board24V/5A | On board12V/2A | |
| Power | 100-240V AC | 100-240V AC | |
| Battery lifecycle | ● 100% Depth ofDischarge 200cycles↑● 80% Depth ofDischarge 225cycles | ● 100% Depth ofDischarge400cycles ↑● 50% Depth ofDischarge | Different |
| Category | C.T.M. MobilityScooter, HS-328New device | C.T.M. MobilityScooter #HS-295K070603 | Result ofComparasion |
| ↑● 50% Depth ofDischarge 500cycles↑ | 800cycles ↑● 30% Depth ofDischarge2400cycles ↑ | ||
| Seat Type | Swivel Light WeightFoldable | Swivel Padded Foldable | Different |
| Seat Width | 460 mm / 18" | 434mm / 17" | Different |
| Seat upholsterymaterials | Vinyl upholstery & PUfoam | Vinyl upholstery & PUfoam | Same |
| Accessaries | IFU, key switch,armrests, front basketand Optional Rear Light | IFU, key switch,armrests, and frontbasket | Different |
| Use Parameters | |||
| Targetpopulation | Elderly and disabled | Elderly and disabled | Same |
| Suitability | Indoor and outdoor | Indoor and outdoor | Same |
| Weight bearingCapacity | 136 kg / 300 lbs | 136 kg / 300 lbs | Same |
| ElectromagneticImmunity Level | 20V/m | 20V/m | Same |
| the maximumdistance oftravel on thefully chargedbattery | 17.5 km / 10.9 Miles | 10 km / 6.2 Miles | Different |
| Speed limitsForward | Yes | Yes | Same |
| Slow control | 1kmh/0.6mph | 1kmh/0.6mph | |
| High control | 8 kmh / 5 mph | 8 kmh / 5 mph | |
| Reverse | 2.7 kmh / 1.7 mph | 2.7 kmh / 1.7 mph | |
| Category | C.T.M. MobilityScooter, HS-328New device | C.T.M. MobilityScooter #HS-295K070603 | Result ofComparasion |
| GroundClearance | 52 mm / 2" | 40 mm / 1.6" | Different |
| GradeClimbable | 8 degree | 8 degree | Same |
| Curb Climbable | 40 mm / 1.6" | 32.5 mm / 1.3" | Different |
| Turning Radius | 1450 mm / 57.1" | 1270 mm / 50" | Different |
| Storage(especiallybattery) | -15℃ | -15℃ | Same |
| Labeling | Instructions for use Product Brochure Product Labels Charger box label. Carton label. | Instructions for use Product Brochure Product Labels Charger box label. Carton label | same |
| Packaging | Charger box with plastic bag: Charger adapter x 1 pc and key x 1 pc Carton box. | Charger box with plastic bag: Charger adapter x 1 pc and key x 1 pc Carton box. | Same |
| Compliance standard | |||
| Biocompatibility | ISO10993-5ISO10993-10 | ISO10993-5ISO10993-10 | Same |
| Electrical safety | IEC60601-1 | IEC60601-1 | Same |
| EMC | IEC60601-1-2 | IEC60601-1-2 | Same |
| Software | IEC62304(by controller) | IEC62304(by controller) | Same |
| performance | ISO7176 series | ISO7176 series | Same |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a logo for C.T.M. The logo is in an oval shape with a gray border. The letters C.T.M. are in red and are in the center of the oval. There are blue swooshes above and below the letters.
CHIEN TI ENTERPRISE CO., LTD. No. 13, Lane 227, Fu Ying Rd,. Hsin Chuang District, New Taipei City, Taiwan
Tel : +886-2-2903-2987 Fax : +886-2-2904-1170 • 2903-8807 E-Mail : sales@chienti.com.tw http://www.chienti.com.tw
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image is a logo for C.T.M. The logo is an oval shape with a gray border. The letters "C.T.M." are in red, and there are blue swooshes above and below the letters.
CHIEN TI ENTERPRISE CO., LTD. No. 13, Lane 227, Fu Ying Rd,. Hsin Chuang District, New Taipei City, Taiwan
Tel : +886-2-2903-2987 Fax : +886-2-2904-1170 · 2903-8807 E-Mail : sales@chienti.com.tw http://www.chienti.com.tw
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a logo for C.T.M. The logo is in an oval shape with a gray background. The letters C.T.M. are in red and are in the center of the oval. There are blue swooshes above and below the letters.
CHIEN TI ENTERPRISE CO., LTD.
No. 13, Lane 227, Fu Ying Rd,. Hsin Chuang District, New Taipei City, Taiwan Tel : +886-2-2903-2987 Fax : +886-2-2904-1170 · 2903-8807 E-Mail : sales@chienti.com.tw http://www.chienti.com.tw
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image is a logo for C.T.M. The logo is in an oval shape with a gray border. The letters C.T.M. are in red and are in the center of the oval. There are blue swooshes above and below the letters.
CHIEN TI ENTERPRISE CO., LTD. No. 13, Lane 227, Fu Ying Rd,. Hsin Chuang District, New Taipei City, Taiwan
Tel : +886-2-2903-2987 Fax : +886-2-2904-1170 · 2903-8807 E-Mail : sales@chienti.com.tw http://www.chienti.com.tw
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image is a logo for C.T.M. The logo is in an oval shape with a gray border. The letters C.T.M. are in red and are in the center of the oval. There are blue swooshes above and below the letters.
CHIEN TI ENTERPRISE CO., LTD. No. 13, Lane 227, Fu Ying Rd,. Hsin Chuang District, New Taipei City, Taiwan Tel : +886-2-2903-2987 Fax : +886-2-2904-1170 · 2903-8807 E-Mail : sales@chienti.com.tw http://www.chienti.com.tw
Non-clinical tests
The safety tests, such as biocompatibility and electrical safety have been performed and meet the requirement of following FDA Recognized Consensus Standards.
Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device.
- 7176-1 Wheelchairs - Part 1: Determination of static stability ISO
- ISO 7176-2 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes
- 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs and ● ISO scooters for determination of theoretical distance range
- 7176-5 Wheelchairs - Part 5: Determination of overall dimensions, mass and ISO manoeuvring space
- ISO 7176-6 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- 7176-7 Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO
- ISO ● 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered ISO wheelchairs and scooters - Requirements and test methods
- ISO 7176-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-16 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- 7176-21 Wheelchairs - Part 21: Requirements and test methods for electromagnetic ISO compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-22 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25 Wheelchairs -- Part 25: Batteries and chargers for powered wheelchairs
Clinical study
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image is a logo for C.T.M. The logo is in an oval shape with a gray border. The letters C.T.M. are in red and are in the center of the oval. There are blue swooshes above and below the letters.
CHIEN TI ENTERPRISE CO., LTD. No. 13, Lane 227, Fu Ying Rd,. Hsin Chuang District, New Taipei City, Taiwan +886-2-2903-2987 Fax : +886-2-2904-1170 · 2903-8807 E-Mail : sales@chienti.com.tw http://www.chienti.com.tw
This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
Conclusions:
C.T.M. Mobility Scooter, HS-328 has the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, C.T.M. Mobility Scooter, HS-328 is substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics.
§ 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).