Luggie Chair

K160139 · Freerider Corporation · ITI · Mar 20, 2017 · Physical Medicine

Device Facts

• Record ID: K160139
• Device Name: Luggie Chair
• Applicant: Freerider Corporation
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Indications for Use

The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

Device Story

The FR-W04 (Luggie Chair) is a battery-powered, four-wheeled electric wheelchair for mobility-impaired individuals. It supports a single rider up to 360 lbs. The device features rear-wheel drive, regenerative electromechanical braking, and an adjustable seat. The user operates the chair via a controller mounted on the armrest, using a lever and speed knobs to manage direction and velocity. It is intended for use in indoor and outdoor environments. The device provides mobility, potentially increasing independence for the user. It is a non-clinical, bench-tested powered mobility aid.

Clinical Evidence

No clinical data. Bench testing only, including electromagnetic interference (IEC 6100-4-2/3/8, EN 55011/55022), ISO 7176 series (multiple sections), ISO 10993-1/5/10 (biocompatibility), and IEC 60601-1 (electrical safety).

Technological Characteristics

Battery-powered (24V, 10.5Ah Lithium) four-wheeled electric wheelchair. Features: rear-wheel drive, regenerative electromechanical brakes, Dynamic LiNX 40A controller, foldable seat/footrest. Dimensions: 37.44" L x 23.86" W. Max weight capacity: 360 lbs. Standards: ISO 7176, IEC 60601-1, ISO 10993, IEC 6100-4 series. Off-board AC-DC charger (100V-240V).

Indications for Use

Indicated for elderly or disabled persons requiring mobility assistance for transportation in indoor and outdoor settings. No specific age or gender contraindications stated.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Freerider FR 168-W Power chair (K033370)
• Freerider FR-L05 Luggie Super (K151944)

Submission Summary (Full Text)

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March 20, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Freerider Corporation Michael Chen R&D Department and Assistant Vice President No. 22 Bengong 5th Road Kang-Shan District, TW

Re: K160139

Trade/Device Name: Luggie Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 7, 2017 Received: March 17, 2017

Dear Mr. Chen:

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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

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# Indications for Use

510(k) Number (if known) K160139

Device Name Luggie Chair

Indications for Use (Describe)

The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary K160139

## 1. Contact Details

Applicant Name: Freerider Corporation

No. 22, Bengong 5th Road Kang-Shan Dist, Kaohsiung 820, Taiwan

| Contact Name: | Michael Chen |
|---------------|---------------------------------------|
| | Freerider Corporation |
| | No. 22, Bengong 5th Road |
| | Kang-Shan Dist, Kaohsiung 820, Taiwan |
| | Phone: [phone] |
| | Fax: [phone] |

Date Prepared: Nov 03, 2015

### 2. Device Name

Trade Name: Luggie Chair Common Name: Powered Wheelchair Classification Code: ITI Regulation Number: 21 CFR 890.3860

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------|--------------|-----------------------------------|-----------------|
| K033370 | ITI | Freerider FR 168-W<br>Power chair | Freerider Corp. |
| K151944 | INI | Freerider FR-L05<br>Luggie Super | Freerider Corp. |

#### 3. Legally Marketed Predicate Device(s)

### 4. Device Description

The FR-W04 (Luggie Chair) is a battery-powered, four-wheeled electric wheelchair intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-W04 (Luggie Chair) is meant to be used by a single rider weighing up to 360 pounds. The wheelchair is rear-wheel drive and has electric, regenerative electromechanical brakes. The steering and user controls are provided on the armrest for ease of use by the rider. Steering is

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controlled simply by turning the top controller in the desired direction. There is one lever, and speed knobs on the top controller to control movement speed of the wheel chair. The specification of control method is the same as the predicate device, Freerider FR168-W Power Chair (K033370).

The FR-W04 (Luggie Chair) has a controller and one lithium battery. There is also an off-board battery charger, which has also been previously cleared. It has an adjustable seat that has several height adjustments. The specification of battery charger and adjustable seat is the same as the predicate device, Freerider Luggie Super FR-L05 (K151944).

### 5. Intended Use/Indications for use

The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

| | K160139 (subject device) | K033370 (predicate) | K151944 (predicate) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device<br>Characteristics | | | |
| Manufacturer | Freerider | Freerider | Freerider |
| Model | FR-W04 (Luggie<br>Chair) | FR168W | Luggie Super |
| Indications for Use | The FR-W04<br>(Luggie Chair)<br>provides<br>transportation for an<br>elderly or disabled<br>person. It can be<br>used in a variety of<br>indoor and outdoor<br>settings. | The fr168w<br>powered<br>wheelchair<br>provides<br>transportation<br>for an elderly<br>or disabled<br>person. It can<br>be used in a<br>variety of<br>indoor and<br>outdoor<br>settings. | The FR-L05<br>(Luggie Super)<br>provides<br>transportation<br>for an elderly or<br>disabled person.<br>It can be used in<br>a variety of<br>indoor and<br>outdoor settings. |
| Framework | Folding seat and | | Folds for |
| | footrest | | transport |
| | Adjustable height | | |
| Overall Dimensions | | | |
| Length (in) | 37.44 | 32 | 39 |
| Width (in) | 23.86 | 22 | 20.7 |
| Height (in) | 30.11-33.11 | 40 (46 with<br>headrest) | 35.7 |
| Seat Dimensions | | | |
| Width (in) | 17 | | 16.9 |
| Depth (in) | 15.43 | | 13.2 |
| Height (in) | 8.98 | | 17.3 |
| Folded Dimensions (if<br>applicable) | | | |
| Length (in) | 31.73 | | 27.76 |
| Width (in) | 23.86 | | |
| Height (in) | 17 (w/o armrest) | | |
| Wheelchair Weight | | | |
| With batteries | 76.56 lbs. | 84.5 lbs. | 67.1 lbs. |
| Without batteries | 71.72 lbs. | 84.5 lbs. | 62.26 lbs. |
| Controller | Dynamic 40A | P&G VSI<br>Controller | Rhino R-series<br>50 |
| Motor (include output) | 2 | 2 | 1 |
| | 24V | 0.339hp | |
| Batteries | | | |
| Quantity | 1 | 2 | 1 |
| Type | Lithium<br>24V, 10.5Ah | 12V, U-1<br>sealed | Lithium<br>24V 10.5 Ah |
| Range per Charge | 8.19 mi (198 lbs.)<br>6.31 miles (360 lbs.) | 25 mi | 10.5 mi (198 lbs)<br>7.25 miles (360 lbs) |
| Charger | Off board<br>Switching Mode AC-DC<br>100V~240V 50/60Hz<br>Output :5A | Onboard standard, off board optional<br>4A<br>110V | Off board<br>Switching Mode AC-DC<br>100V~240V 50/60Hz<br>Output :5A |
| Actuator | Dynamic LiNX 40A module | | |
| Brake | Electronic regenerative, electromechanical | Electronic regenerative | Electronic regenerative, electromechanic al |
| Minimum braking distance | | | |
| Forward (in) | 73.14 | 44.8 | 75.9 |
| Reverse (in) | 30.87 | | 47.2 |
| Max speed | | | |
| Forward | 4 mph | 4 mph | 4 mph |
| Reverse | 2.4 mph | 3.8 mph | 2.4 mph |
| Rear Wheels (in) | 2 x 8 | 10 | 2 x 7 |
| Castors (in) | 2 x 7 | 8 | 2 x 6 |
| Anti-tip wheels | 2.55 in | 6 in | Yes |
| Max Weight Capacity | 360 lbs. | 300 lbs. | 360 lbs. |
| Curb Climbing ability | 0.98 in | | |
| Ground clearance | 1.22 in | | 2.13 in |
| Minimum Turning Radius | 30.7 in | 26 in | 41.3 in |
| Maximum Incline (°) | 6 | 5 | 6 |
| Footplates | Foldable | | |
| Armrest Type | Fold up | | |
| Warranty | Provided | | |

#### 6. Substantial Equivalence Comparison

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The control method of the FR-W04 (Luggie chair) is substantially equivalent to Freerider FR168-W (K033370).

The device features of the FR-W04 (Luggie Chair) and the FR168-W (K033370) are similar. Both are electric wheelchairs that are battery operated and have automatic breaking systems. Operating mode and interface are very similar, the control lever is mounted on an armrest, and directional control is the same as FR168-W (K033370). The differences are as follows: The FR-W04 has an adjustable seat that has several height adjustments. The front and rear wheels are 7" and 8" respectively, smaller than that of the FR168-W (K033370).

The battery with charger and adjustable seat features on the FR-W04 (Luggie Chair) is substantially equivalent to that of the FR-L05 Luggie Super (K151944). The device features of the FR-W04 (Luggie Chair) and the FR-L05 Luggie Super (K151944) are similar. Both are battery operated and have automatic breaking systems. The charger and adjustable seat is the same between the two devices. The differences are as follows: The control lever of the FR-W04 is mounted on the armrest. The FR-W04 does not have a front handle bar and front chassis.

#### 7. Non-clinical Testing

Electromagnetic interference testing was conducted to IEC 6100-4-2, IEC 6100-4-3, IEC 6100-4-8, EN 12184:2009, EN 55011:2010, and EN55022. ISO 7176 testing to multiple sections; Section 1, Section 2, Section 4, Section 5, Section 6, Section 6, Section 7, Section 8, Section 9, Section 10, Section 11, Section 14, Section 14, Section 15, Section 16, and Section 21 was conducted, as well as ISO 10993-1, ISO 10993-5, ISO 10993-10 and IEC60601-1. Additional bench testing related to ground current leakage and summary matrix testing was also conducted. The FR-W04 (Luggie Chair) passed all testing.

## 8. Clinical Testing

No clinical testing is included in this submission.

### 9. Conclusion

The safety and effectiveness of the FR-W04 (Luggie Chair) was demonstrated by the

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testing in compliance with national and international standards. The intended use, basic technology, and many features of the FR-W04 (Luggie Chair) are similar to the predicate device. No new issues of safety and effectiveness are raised by the differences between the FR-W04 (subject device), FR168-W (K033370), and FR-L05 Luggie Super (K151944). Therefore, the subject device is substantially equivalent to the predicate devices.