(39 days)
No
The description focuses on the mechanical aspects and standard performance testing of a wheelchair, with no mention of AI or ML technologies.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device provides mobility assistance, which is a supportive function, not a treatment.
No
The device description states its purpose is to provide mobility and does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a "Mechanical Wheelchair" with physical components like a base, wheels, seat, and upholstery, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide mobility to persons restricted to a sitting position." This describes a physical aid for mobility, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a mechanical wheelchair with features related to mobility, comfort, and safety (flame retardant upholstery). There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key aspects typically associated with IVDs, such as:
- Image processing
- AI, DNN, or ML (often used in analyzing diagnostic data)
- Input Imaging Modality
- Anatomical Site
- Description of training/test sets and performance studies related to diagnostic accuracy (instead, performance studies focus on wheelchair standards).
- Key Metrics like Sensitivity, Specificity, PPV, NPV (these are metrics for evaluating diagnostic test performance).
In summary, the device's purpose, description, and the absence of IVD-specific information clearly indicate that it is a mobility aid and 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 restricts to a seated position.
Product codes
IOR
Device Description
The AVANTICARE Mechanical Wheelchair, MR-9000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
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)
Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
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
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows a logo for Lerado Group, with the text "LERADO" in large, stylized letters above the words "LERADO GROUP" in smaller font. A triangle is used as the "A" in Lerado. Below the English text is Chinese text. Above the logo is the date "APR 26 2005".
RADO OVERSEA LTD. TWN BRANCH(BVD) No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Fax: 886-5-2379672 Tel: 886-5-2475520 E-mail.edwardl.@mail.lerado.com http:// www.lerado.com
દ ૯ 510(k) SUMMARY "
Submitter's Name: Lerado Oversea Ltd. Twn Branch (BVI) No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Taiwan, ROC. Hsien, 612,
Date summary prepared:
March 11, 2005
Device Name:
Proprietary Name:
LERADO,
Common or Usual Name: Classification Name:
AVANTICARE Mechanical Wheelchair, MR-9000 Mechanical Wheelchair Mechanical Wheelchair, Class I. 21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricts to a seated position.
Description of the device:
The AVANTICARE Mechanical Wheelchair, MR-9000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
AVANTICARE Mechanical Wheelchair, MS-8000 ( K050290 )
1
2/2
Image /page/1/Picture/2 description: The image shows the logo for LEARDO GROUP. The logo is black and white and features the company name in a stylized font. Above the company name is a triangular shape. Below the company name is the Chinese translation of the company name.
LERADO OVERSEA LTD. TWN BRANCH(BVI) No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Fax: 886-5-2379672 Tel: 886-5-2475520 E-mail :edwardl :@mail.lerado.com http:// www.lerado.com
Summary for substantial equivalence comparison:
The new device and the predicate device have the same intended use Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame The major differences existing are the overall dimension and retardant. the weight capacity. The overall appearance differences are not safety So the new device is substantially equivalent to the predicate device.. aspect.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Public Health Service
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lerado Oversea Ltd. TWN Branch (BVI) C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 22, Kuang Fu Road Chia Tai Industrial Tai Pao City Chia Yi Hsien, Taiwan ROC
Re: K050708
R030700
Trade/Device Name: Lerado, Avanticare Mechanical Wheelchair, MR-9000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 30, 2005 Received: April 7, 2005
Dear Dr. Ke-Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave levice your beeting of 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 enciosure) to legally marketed proutents, or to devices that have been reclassified in accordance enacifient uail of the Medical Device I.Meneral Act (Act) that do not require approval of a with the provisions of the readial PMA). You may, therefore, market the device, subject to the general prematics approval approvation (1111). controls provisions of the rec. The general seuring 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 may be If your device is elaisined (ood also regulations affecting your device can be found in the Subject to such additional controlly - Entrally - 1-11-2001 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 I'DA I lease be advised that 1 127 a roundevice complies with other requirements of the Act or any Federal flas made a decemmiations administered by other Federal agencies. You must comply with all the Act of C statules and regulations administered of ourself on and listing (21 CFR Part 807); labeling (21 CFR Part requirements, mending, but not mined to requirements as set forth in the quality systems (QS) regulation (2) CFR 801), good mailtracturing product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I his letter will anow you to ovegin manential equivalence of your device to a legally marketed predicate notification. The IT2A iniding of substantial equivalence or 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 If you desire specific at rice for your ave a views note the regulation entitled, "Misbranding by Office of Compunatic at (240) 276 - 1120, p.m. 907.97). You may obtain other general information on reference to premation (21 OFF C Fer C Fe' C Fe' C L C C Small Manufacturers, International and Consumer your responsibilities ander and 110-11-2019 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypk Rurder
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
and the started to the state the state of the more of the may be and
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________ K
12-26-2018 - 11:42
Device Name: LERADO, AVANTICARE Mechanical Wheelchair, MR-9000
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 √
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
1 87 Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number: K050708
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