K Number
K160139
Device Name
Luggie Chair
Date Cleared
2017-03-20

(424 days)

Product Code
Regulation Number
890.3860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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 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).
More Information

No
The description details a standard electric wheelchair with basic controls and safety features, with no mention of AI or ML capabilities.

No.
The device is described as an electric wheelchair providing transportation and mobility, which is a supportive function rather than a therapeutic one.

No

The device description indicates it is a "battery-powered, four-wheeled electric wheelchair intended to provide mobility," which is a therapeutic function rather than a diagnostic one.

No

The device description clearly outlines a physical, battery-powered electric wheelchair with hardware components like wheels, brakes, a controller, a battery, and a charger. It is not solely software.

Based on the provided information, the FR-W04 (Luggie Chair) is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is to provide transportation for an elderly or disabled person. This is a mobility aid, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition.
  • Device Description: The description details a battery-powered electric wheelchair with features related to mobility, control, and comfort. There is no mention of analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing blood, urine, tissue, or other bodily fluids.
    • Detecting biomarkers or specific substances.
    • Providing diagnostic results.
    • Using reagents or assays.

The FR-W04 (Luggie Chair) is clearly a medical device, but it falls under the category of a mobility aid, not an in vitro diagnostic device.

N/A

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.

Product codes

ITI

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 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).

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 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.
Clinical Testing: No clinical testing is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K033370, K151944

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 890.3860 Powered wheelchair.

(a)
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.(b)
Classification. Class II (performance standards).

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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 (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 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: 886-7-6223093
Fax: 886-7-6230373

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) NumberProduct CodeTrade NameManufacturer
K033370ITIFreerider FR 168-W
Power chairFreerider Corp.
K151944INIFreerider FR-L05
Luggie SuperFreerider 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

4

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
Characteristics
ManufacturerFreeriderFreeriderFreerider
ModelFR-W04 (Luggie
Chair)FR168WLuggie Super
Indications for UseThe FR-W04
(Luggie Chair)
provides
transportation for an
elderly or disabled
person. It can be
used in a variety of
indoor and outdoor
settings.The fr168w
powered
wheelchair
provides
transportation
for an elderly
or disabled
person. It can
be used in a
variety of
indoor and
outdoor
settings.The FR-L05
(Luggie Super)
provides
transportation
for an elderly or
disabled person.
It can be used in
a variety of
indoor and
outdoor settings.
FrameworkFolding seat andFolds for
footresttransport
Adjustable height
Overall Dimensions
Length (in)37.443239
Width (in)23.862220.7
Height (in)30.11-33.1140 (46 with
headrest)35.7
Seat Dimensions
Width (in)1716.9
Depth (in)15.4313.2
Height (in)8.9817.3
Folded Dimensions (if
applicable)
Length (in)31.7327.76
Width (in)23.86
Height (in)17 (w/o armrest)
Wheelchair Weight
With batteries76.56 lbs.84.5 lbs.67.1 lbs.
Without batteries71.72 lbs.84.5 lbs.62.26 lbs.
ControllerDynamic 40AP&G VSI
ControllerRhino R-series
50
Motor (include output)221
24V0.339hp
Batteries
Quantity121
TypeLithium
24V, 10.5Ah12V, U-1
sealedLithium
24V 10.5 Ah
Range per Charge8.19 mi (198 lbs.)
6.31 miles (360 lbs.)25 mi10.5 mi (198 lbs)
7.25 miles (360 lbs)
ChargerOff board
Switching Mode AC-DC
100V~240V 50/60Hz
Output :5AOnboard standard, off board optional
4A
110VOff board
Switching Mode AC-DC
100V~240V 50/60Hz
Output :5A
ActuatorDynamic LiNX 40A module
BrakeElectronic regenerative, electromechanicalElectronic regenerativeElectronic regenerative, electromechanic al
Minimum braking distance
Forward (in)73.1444.875.9
Reverse (in)30.8747.2
Max speed
Forward4 mph4 mph4 mph
Reverse2.4 mph3.8 mph2.4 mph
Rear Wheels (in)2 x 8102 x 7
Castors (in)2 x 782 x 6
Anti-tip wheels2.55 in6 inYes
Max Weight Capacity360 lbs.300 lbs.360 lbs.
Curb Climbing ability0.98 in
Ground clearance1.22 in2.13 in
Minimum Turning Radius30.7 in26 in41.3 in
Maximum Incline (°)656
FootplatesFoldable
Armrest TypeFold up
WarrantyProvided

6. Substantial Equivalence Comparison

5

6

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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.