(19 days)
Not Found
No
The description focuses on basic mechanical and electrical components and control via hand controls, with no mention of AI/ML terms or functionalities.
Yes
Explanation: The device, a power wheelchair, is intended to provide mobility to individuals restricted to a sitting position, which qualifies as a therapeutic purpose.
No
The device is described as a powered wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly states it is a "Powered Wheelchair" with a physical base, wheels, seat, hand controls, and battery. This indicates it is a hardware device, not software-only.
No, 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 sitting position. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a powered wheelchair, a device for physical mobility. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other typical components of an IVD.
- Performance Studies: The performance studies listed are related to electrical and mechanical safety and performance of a wheelchair, not the accuracy or reliability of a diagnostic test.
An In Vitro Diagnostic (IVD) device is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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
ITI
Device Description
The LERADO, AVANTICARE Power Wheelchair, PW-1800 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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 onboard battery charger.
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:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
Image /page/0/Picture/0 description: The image shows a logo for Lerado Group. The logo includes the text "LERADO" in a bold, stylized font, with a triangle in place of the letter "A". Below the main text, the words "LERADO GROUP" are written in a smaller font. Above the logo, the date "FEB - 1 2005" is printed.
LERADO OVERSEA LTD. TWN BRANCH(BVI) No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-5-2475520 Fax: 886-5-2379672 E-mail.edwardl.@mail.lerado.com http:// www.lerado.com
K 050087
January 9, 2005
510(k) SUMMARY " દ ૮
Submitter's Name: Lerado Oversea Ltd. Twn Branch (BVI)
No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Hsien, 612, Taiwan, ROC
Date summary prepared:
Device Name:
LERADO, AVANTICARE Power Wheelchair, PW-1800 Proprietary Name: Powered Wheelchair Common or Usual Name: Powered Wheelchair, Class II, Classification Name: 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:
The LERADO, AVANTICARE Power Wheelchair, PW-1800 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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 onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
SINON Power Wheelchair, SN-W401 (K
1
Image /page/1/Picture/0 description: The image shows the logo for "LERADO GROUP". The logo is in black and white and features the word "LERADO" in large, bold letters. Below the word "LERADO" is the word "LERADO" again, followed by the word "GROUP" and some Chinese characters.
LERADO OVERSEA LTD. TWN BRANCH(BVI) No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-5-2475520 Fax: 886-5-2379672 E-mail:edwardI_@mail.lerado.com
C.1 SUMMARY TABLE
| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| BRAND NAME | AVANTICARE | SINON |
| MANUFACTURER | LERADO group | SINON Corporation |
| SERIES | Power wheelchair | Power wheelchair |
| MODEL NO | PW-1800 | SN-W401 |
| 510K NO | TBA | K040319 |
| INTENDED USE | SAME | The device is |
| intended for medical | ||
| purposes to provide | ||
| mobility to persons | ||
| restricted to a sitting | ||
| position. | ||
| Frame | SAME | FOLDABLE |
| Overall dimension | SAME | |
| Overall length | SAME | 102 cm / 40-1/8" |
| Overall width | SAME | 61 cm / 24" |
| Overall height | SAME | 99cm / 39" |
| Weight limit | SAME | 115 kgs / 250 lbs |
| Maximum speed | SAME | 4 mph / 6.4 km |
| Electronics | SAME | Dynamic DL controller |
| Batteries | ||
| Quantity | Two | Two |
| Type | U1, 34Ah 12VDC* 2 | U1, 38Ah 12VDC* 2 |
| Range per charge | SAME | 20 miles / 32 km |
2
Image /page/2/Picture/0 description: The image shows the logo for "LERADO GROUP". The logo consists of the word "LERADO" in large, bold letters, with a stylized tree symbol between the "R" and the "A". Below the word "LERADO", there is the text "LEARDO GROUP" in smaller letters. Underneath that, there are four Chinese characters.
LERADO OVERSEA LTD. TWN BRANCH(BVI) No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-5-2475520 Fax: 886-5-2379672 E-mail:edwardl_@mail.lerado.com http:// www.lerado.com
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
Owing to the predicate device SN-W401and the new device PW-1800 are made by the same designer that the same specifications for the two independent organizations to use the different brand that means the predicate device for the SINON corporation and the new device for the LERADO group. Thus, from the above table and appearances that the intended use between the two devices is the same. The batteries for the two devices are used the same brand and similar U1 type. The control systems for the two devices are from the same supplier, it is Dynamic DL 50 series type for the two devices. The recharge for the two devices are also used the same resource, HP8204B, and the recharger is certified by UL.
Besides, the same foldable frame, same removable arm type, same weight limit, same maximum speed, same incline degree, same cruising range, and back uphostery are the same material that also be passed the resistance ignition test by SGS. Fiven the two devices are the same overall dimensions, the same size of wheels, and seat dimensions.
To sum up, the mainly different of the two devices are only the two devices use the different but similar type batteries, i.e., the 34Ah for the new device, and the 38As for the predicate device. The two type batteries are from the same supplier, and also certified by UL. The differences for the two devices do not lead to any performance differences, thus they are substantially equivalent.
Based on the above the information and the analysis, we know that the subject device, 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 daride the subject device and the predicate device are substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Ke-Min Jen Lerado Oversea LTD. TWN Branch (BVI) C/o Roc Chinese-European Industrial No. 58. Fu-Chiun St. Hsin-Chu City, China, Taiwan 30067
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K050087
Device Name: Lerado, Acanticare Power Wheelchair, PW-1800 Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 9, 2005 Received: January 13,2005
Dear Dr. Ke-Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of 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). and Cosmeter For (110) that the device, subject to the general controls provisions of the Act. The r ou may, iterefore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de roo to such additional controls. Existing major regulations affecting your device it may be succeed to 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 I touse oc arrison that I Drimination that your device complies with other requirements of the Act that I Drillas Intatutes and regulations administered by other Federal agencies. You must or any I ederal statutes and entry including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quality by well provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/3/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and h your your finding of substantial equivalence of your device to a legally prereeted predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division Of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K 510 (K) Number ( If Known ):
Device Name: LERADO, AVANTICARE Power Wheelchair, PW-1800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use
in in intellection and souther in the states of the stames and the land
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K050087