C.T.M. Mobility Scooter

{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. 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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. Mobility<br>Scooter, HS-328<br>New device | C.T.M. Mobility<br>Scooter #HS-295<br>K070603 | Result of<br>Comparasion | |-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | Indications for<br>Use (IFU)<br>statement | The C.T.M. Mobility<br>Scooter HS-328 in an<br>indoor/outdoor scooter<br>that provides<br>transportation for a<br>disabled or elderly<br>person. | The C.T.M. Mobility<br>Scooter HS-295 is an<br>indoor/outdoor scooter<br>that provides<br>transportation for a<br>disabled or elderly<br>person. | Same | | The generic<br>name of the | Electric scooter | Electric scooter | Same | | Category | C.T.M. Mobility<br>Scooter, HS-328<br>New device | C.T.M. Mobility<br>Scooter #HS-295<br>K070603 | Result of<br>Comparasion | | device | | | | | Classification<br>name | 890.3800 Motorized<br>3-wheeled vehicle | 890.3800 Motorized<br>3-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 weight<br>With battery | 55 kg / 121.3 lbs | 49 kg / 109 lbs | Different | | Weight Of<br>Heaviest Piece | 17 kg / 37.5 lbs | 17.8 kg / 39.2 lbs | Different | | Color of Cover | Ice Blue, Burgundy and<br>Silver | Burgundy 、Silver、Blue | Different | | Dismantle for<br>transport? | Yes | Yes | Same | | Drive<br>technology | Rear-wheel drive | Rear-wheel drive | Same | | Suspension | Rear (Option) | N/A | Different | | Motors –<br>Number<br>Size | 1<br>250W, 4000 r.p.m | 1<br>250W, 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 | | Wheels<br>materials | PU foaming caster<br>Rim Material: PA+GF<br>Tire Type: filling PU<br>rubber | PU foaming caster<br>Rim Material: PA+GF<br>Tire Type: filling PU<br>rubber | Same | | Category | C.T.M. Mobility<br>Scooter, HS-328<br>New device | C.T.M. Mobility<br>Scooter #HS-295<br>K070603 | Result of<br>Comparasion | | Anti-tip wheels | Yes | Yes | Same | | Controller | Dynamic Rhino 50 | Dynamic Rhino 50 | Same | | Function of Control panel | | | | | On/off<br>switches | Yes | Yes | Same | | Speed Hi/Lo<br>Dial knob | Yes | Yes | Same | | Battery gauge<br>indicator | Yes | Yes | Same | | Self-Diagnostic<br>Warning Lig | Yes | Yes | Same | | Throttle | Yes | Yes | Same | | Horn Button | Yes | Yes | Same | | Rear<br>Position light | Yes (optional accessary) | No | Different | | Battery –<br>Number | 2 | 2 | Different | | Type | Rechargeable Sealed<br>Lead-Acid<br>12V/22Ah | Rechargeable Sealed<br>Lead-Acid 12V/12Ah | | | Size<br>weight | 15.5 kg / 34.2 lbs | 10.4 kg / 23 lbs | | | Battery charger | | | Different | | Availability | Off-board<br>24V/5A | On board<br>12V/2A | | | Power | 100-240V AC | 100-240V AC | | | Battery life<br>cycle | ● 100% Depth of<br>Discharge 200cycles<br>↑<br>● 80% Depth of<br>Discharge 225cycles | ● 100% Depth of<br>Discharge<br>400cycles ↑<br>● 50% Depth of<br>Discharge | Different | | Category | C.T.M. Mobility<br>Scooter, HS-328<br>New device | C.T.M. Mobility<br>Scooter #HS-295<br>K070603 | Result of<br>Comparasion | | | ↑<br>● 50% Depth of<br>Discharge 500cycles<br>↑ | 800cycles ↑<br>● 30% Depth of<br>Discharge<br>2400cycles ↑ | | | Seat Type | Swivel Light Weight<br>Foldable | Swivel Padded Foldable | Different | | Seat Width | 460 mm / 18" | 434mm / 17" | Different | | Seat upholstery<br>materials | Vinyl upholstery & PU<br>foam | Vinyl upholstery & PU<br>foam | Same | | Accessaries | IFU, key switch,<br>armrests, front basket<br>and Optional Rear Light | IFU, key switch,<br>armrests, and front<br>basket | Different | | Use Parameters | | | | | Target<br>population | Elderly and disabled | Elderly and disabled | Same | | Suitability | Indoor and outdoor | Indoor and outdoor | Same | | Weight bearing<br>Capacity | 136 kg / 300 lbs | 136 kg / 300 lbs | Same | | Electromagnetic<br>Immunity Level | 20V/m | 20V/m | Same | | the maximum<br>distance of<br>travel on the<br>fully charged<br>battery | 17.5 km / 10.9 Miles | 10 km / 6.2 Miles | Different | | Speed limits<br>Forward | 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. Mobility<br>Scooter, HS-328<br>New device | C.T.M. Mobility<br>Scooter #HS-295<br>K070603 | Result of<br>Comparasion | | Ground<br>Clearance | 52 mm / 2" | 40 mm / 1.6" | Different | | Grade<br>Climbable | 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<br>(especially<br>battery) | -15℃~40℃ (5~105°F)<br>and 25%~85% | -15℃~40℃ (5~105°F)<br>and 25%~85% | 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 | ISO10993-5<br>ISO10993-10 | ISO10993-5<br>ISO10993-10 | Same | | Electrical safety | IEC60601-1 | IEC60601-1 | Same | | EMC | IEC60601-1-2 | IEC60601-1-2 | Same | | Software | IEC62304<br>(by controller) | IEC62304<br>(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.