(325 days)
Not Found
No
The description focuses on mechanical and electrical control, and there are no mentions of AI, ML, or related concepts. The performance studies are standard tests for powered wheelchairs.
Yes
The device is a powered wheelchair intended to provide mobility to persons restricted to a seated position, which is a therapeutic purpose.
No
The device description explicitly states it is a "Powered Wheelchair" intended "to provide mobility to persons restricted to a seated position," which is a therapeutic function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a "Powered Wheelchair" with a physical base, wheels, seat, battery, and hand controls. The performance studies listed are for physical wheelchair standards, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair, its components, and how it operates. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or calibrators.
The performance studies listed are related to the physical and electrical performance of a wheelchair, not diagnostic accuracy.
Therefore, this device is a medical device for mobility, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
LERADO, Powered Wheelchair, DF4110 series include the devices with the same mechanic and electric controlling structure but with different colors of body and veneer. The LERADO Powered Wheelchair, DF4110 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat and is battery operated. The device can be disassembled for transportation, easily foldable and is provided with an off-board battery charger. The movement of the wheelchair is controlled by the rider who uses hand controls located at the top of the steering column.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
- ANSI / RESNA WC Vol.2 Wheelchair Part 2: Electromagnetic compatibility, 2009. .
- · ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
- ISO7176-2 Wheelchairs Part 2:Determination of electric wheelchairs, 2001.
- · ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
- · ISO7176-4 Wheelchairs Part 4:Determination of energy consumption of electric wheelchairs, 2008.
- · ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.
- · ISO7176-6 Wheelchairs Part 6:Determination of maximum speed, acceleration and retardation of electric wheelchairs, 2001.
- · ISO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 1998.
- · ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
- · ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
- · ISO7176-10 Wheelchairs Part 10:Determination of the climbing ability of electric wheelchairs, 2008.
- · ISO7176-11 Wheelchairs Part 11: Test dummies, 1992.
- · ISO7176-13 Wheelchairs Part 13:Determination of coefficient of friction of test surfaces, 1989.
- · ISO7176-15 Wheelchairs Part 15:Requirements for information disclosure, documentation and labelling, 1996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for Lerado. The logo consists of the word "LERADO" in bold, sans-serif font. The "A" in "LERADO" is replaced by a black triangle. Below the word "LERADO" is the word "DESIGNS" in a smaller font.
Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
K130982 66 510(k) SUMMARY "
Date summary prepared:
December 31, 2013
Submitter's Name: LERADO Global (MACAO Commercial Offshore) Limited
Avenida Marciano Baotista, No.26-54b, 7 Andar, H7 Edif. Centro Com., Chong Fok Macau, China.
Name of Contact Person:
Dr. Jen, Ke-Min Tel: +852-5-2475605 Fax:+852-5-2379627 Email:ceirs.jen@msa.hinet.net
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
LERADO Power Wheelchair, DF4110 Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
LERADO, Powered Wheelchair, DF4110 series include the devices with the same mechanic and electric controlling structure but with different colors of body and veneer. The LERADO Powered Wheelchair, DF4110 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat and is battery operated. The device can be disassembled for transportation, easily foldable and is provided with an off-board battery charger. The movement of the wheelchair is controlled by the rider who uses hand controls located at the top of the steering column.
Performance Testing:
- ANSI / RESNA WC Vol.2 Wheelchair Part 2: Electromagnetic compatibility, 2009. .
- · ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
- ISO7176-2 Wheelchairs Part 2:Determination of electric wheelchairs, 2001.
- · ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
1
Image /page/1/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in bold, sans-serif font, with a triangle in place of the letter "A". Below the word "LERADO" is the word "GROUP" in a smaller, sans-serif font. The logo is simple and modern, and the use of the triangle adds a touch of visual interest.
Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
- · ISO7176-4 Wheelchairs Part 4:Determination of energy consumption of electric wheelchairs, 2008.
- · ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.
- · ISO7176-6 Wheelchairs Part 6:Determination of maximum speed, acceleration and retardation of electric wheelchairs, 2001.
- · ISO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 1998.
- · ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
- · ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
- · ISO7176-10 Wheelchairs Part 10:Determination of the climbing ability of electric wheelchairs, 2008.
- · ISO7176-11 Wheelchairs Part 11: Test dummies, 1992.
- · ISO7176-13 Wheelchairs Part 13:Determination of coefficient of friction of test surfaces, 1989.
- · ISO7176-15 Wheelchairs Part 15:Requirements for information disclosure, documentation and labelling, 1996.
Materials of the subject device:
| Components | Materials | Test regulation |
|---|---|---|
| FRAME | High-Quality SPCC Steel Pipe | CAS# 7439-89-6 |
| SEAT Leather | PVC Leather | EN 1021-1/-2:2006 Resistant to |
| ignition source smouldering | ||
| cigarette, and match flame | ||
| equivalent | ||
| UPHOLSTERY | ||
| FABRIC & LINING | Fabric and Foam | ANSI/BIFMA X5.1-1993, |
| ISO 8191-1/-2, ISO 7176-16: | ||
| resistance to ignition | ||
| TIRE | PU Solid Tire | CAS# 101-68-8 |
2
Image /page/2/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in a bold, sans-serif font, with a triangular shape in place of the "A". Below the word "LERADO" is the word "GROUP" in a smaller font. The logo is black and white.
Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Con. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
Specifications of the subject device:
- . Frame Material: High Quality SPCC Steel Pipe
- Framework: Unfoldable
- Controller: Dynamic Shark 40A ●
- Motor output :
- Motor: ●
Trade name: Chiapua Components Group
Type: GD35D-05T, DC24V Direct Current Carbon Brush Motor
Size: �88.5mm x 109mm
Output: 200W
RPM: 2955RPM
- Battery: 35Ahx12Vx2pcs .
- . Charger : 3A
- Brake : Electromagnetic brake
- Max Speed : 6km/h (4mile/h)
- Continuous trip distance : 20km /12.4mile
- Climbing ability:6°
- Front wheel: 10" PU Solid tire
- Rear wheel : 6" PU Solid tire
- Seat depth : 410 mm (16.1" )
- Seat height: 530 mm (20.9")
- Seat width : 475 mm (18.7" )
- Max loading: 136kgs(300lbs)
- . Available color: black (body), red/yellow/blue (veneer)
- Total weight:70.3 kgs / 155 lbs
- . Ground clearance:48 mm / 1.9"
- Turning diameter : 1,230 mm / 48.4"
- Dimension ( LWH ): 1,040 * 625 * 1,250 mm
3
Image /page/3/Picture/0 description: The image shows the logo for "LERADO DESIGNS". The logo is in black and white, with the word "LERADO" in large, bold letters. The letter "A" in "LERADO" is replaced by a triangle. Below the word "LERADO" is the word "DESIGNS" in smaller letters.
Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
Comparison table
| ITEMS | PREDICATE
DEVICE | SUBJECT DEVICE |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| BRAND NAME | LERADO | LERADO |
| MANUFACTURER | LERADO GROUP | LERADO GROUP |
| MODEL NO | PB Series | DF4110 Series |
| 510K NO | K070433 | K130982 |
| INTENDED USE | The device is
intended for medical
purposes to provide
mobility to persons
restricted to a sitting
position. | SAME |
| Frame | Fixed (unfoldable) | SAME |
| Overall dimension | | |
| Overall length | 650 mm / 25.59" | 1,040 mm / 40.94" |
| Overall width | 600 mm / 23.62" | 625 mm / 24.60" |
| Weight limit | 136 kgs / 300 lbs | SAME |
| Maximum speed | 6.0 km/hr (4mile/h) | SAME |
| Electronics
controller | Dynamic, DA50 | Dynamic, Shark 40A |
| Batteries | | |
| Quantity
Type
Range per charge | Two
36Ah 12VDC
36 km / 22.5 miles | Two
35Ah 12VDC
20 km / 12.4 miles |
| Suspension | Cross brace | SAME |
| Rear wheels | 10" solid x 2" | 6" PU solid tire |
| Casters | 8" solid x 2" | 10" PU solid tire |
| ITEMS | PREDICATE
DEVICE | SUBJECT DEVICE |
| Footplates | ABS | SAME |
| Frame material | High-Quality SPCC Steel
Pipe | SAME |
| Motor | | |
| Trade name | Motion Technology Electric &
Machinery Co., ltd. | Chiapua Components Group |
| Model number | EC82M | GD35D-05T |
| power | 320W | 200W |
| Type | 24VDC Carbon-brush | 24VDC Carbon-brush |
| Diameter | $Φ$ 82mm *149mm | $Φ$ 88.5mm * 109mm |
| Speed | 4600 RPM | 2955 RPM |
| Seat size | | |
| Width | 4661 cm / 1824" | 47.5 cm / 18.70" |
| Depth | 46 cm / 18" | 41 cm / 16.14" |
| Height | 5358 cm / 2123" | 53 cm / 20.86" |
| Incline | 6 degrees | 6 degrees |
| Back
upholstery | Fabric | SAME |
| Armrest types | Flip-backward | SAME |
| Wheelchair
Weight
w/batteries | 87 kgs | 70.3 kgs |
| Charger
Model
Voltage | HIGH POWER
HP8204B
24VDC | HIGH POWER
HP1211B1
24VDC |
| ITEMS | PREDICATE
DEVICE | SUBJECT DEVICE |
| Wheel Lock | Push-to-Lock | SAME |
| Type of brake | Dynamic electromagnetic
brake | SAME |
| Warranty | 3 years: Main frame
1 years: Controller / gear
motor / batteries w/o
exhaustive and wear
parts | SAME |
4
Image /page/4/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in a stylized font, with a triangle in place of the "A". Below the word is the text "LERADO GROUP" in a smaller font. The logo is black and white.
Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
5
Image /page/5/Picture/0 description: The image shows the word "LERADO" in a stylized font. The "A" in the word is replaced by a triangle. Below the word, there is a series of dots and dashes.
Avenida Marciano Baotista. No. 26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
Substantial equivalence comparison discussion:
We know from the above table that the intended use between two devices is the same; and they are from the same LERADO group and the same manufacturer. Mainframes of two devices are not foldable and all meet the strength and fatigue tests, thus they are similar for the material aspects. The overall dimensions are similar. The weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and the warranty are all the same. Back upholstery material is also the same fabric.
Especially, the electronic systems of two devices, for instance the motor, batteries, and charger are from the same supplier, and both are UL-certified. For the electronic controller, the predicate device uses the Dynamic DA series and the subject device use Dynamic Shark series, and both are UL-certified. Thus the same safety level for the two devices is assured.
Incline capabilities for the two devices are the same. The subject device and the predicate device can both drive under 6 degrees of incline. We place the limit of 6 degrees of climbing incline on the page 2 of the Owner's Manual and the user is not allowed to operate the device on the incline over the specified angle. The safety levels of the two devices are the same when operating the devices on the adequate inclines. They are substantially equivalent.
6
Image /page/6/Picture/0 description: The image shows the word "LERADO" in a stylized font. The letters are in black and are spaced apart. The letter "A" is replaced by a black triangle. Below the word "LERADO" is the text "LERADO DESIGNS" in a smaller font.
Avenida Marciano Baotista. No.26-54b, 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China
TEL: 852-5-2475605 FAX: 852-5-2379627
The cruising ranges per charge are different; and the subject device is 12.4 miles and 22.5 miles for the predicate device. Certainly the real range depends on the practical environmental conditions, i.e., loading weight, driving surface, incline angle, and temperature. For the real life use, the two devices are substantially equivalent.
To sum up, the major differences existing between the two devices are the overall dimensions and cruising ranges. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.
Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Lerado Global Limited c/o Dr. Jen, Ke-Min Avenida Marciano Baotista, No. 26-54b, 7 Andar H7 Edif Centro Com. Chong Fok Macau CHINA
Re: K130982
Trade/Device Name: LERADO Power Wheelchair, Model DF4110 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 17, 2014 Received: January 30, 2014
Dear Dr. Ke-Min:
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
8
Page 2 - Dr. Jen, Ke-Min
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Carlos L. Pena -S
Carlos Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K130982
Device Name
LERADO Power Wheelchair, model DF4110
Indications for Use (Describe)
The device 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
FORM FDA 3881 (9/13)
10
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