(11 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.
No
The device is a power wheelchair, intended to provide mobility, not to treat or cure a medical condition.
No
The device description clearly states that the SINON Power Wheelchair is intended to provide mobility, which is a functional purpose, not a diagnostic one. There is no mention of it being used to identify or monitor medical conditions.
No
The device description clearly states it is a "Powered Wheelchair" with a base, wheels, seat, hand controls, and battery. This indicates a physical hardware device, not software only.
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 seated position." This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair, a device for physical mobility. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or treatment based on biological analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is clearly a mobility aid.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes
ITI
Device Description
The SINON Power Wheelchair, SN-W401 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
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
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
January 28, 2004
SINON CORPORATION
FEB 2 0 2004
23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan TEL : 086-4-23726181
FAX:886-4-23750574
F-mail service(a)sinon.com tw http://www.sinon.com tw
44 510(k) SUMMARY "
Submitter's Namc: SINON Corporation
No. 23, Sec. 1, Mei Chuan W. Road, Taichung, 403, Taiwan, ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
SINON Power Wheelchair, SN-W401 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:
The SINON Power Wheelchair, SN-W401 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:
EPW Foldable Power Wheelchair EPW-03 (K033206)
1
SINON CORPORATION 23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan FAX : 886-4-23750574 TEL:886-4-23726181
http://www.sinon.com.tw F-mail.service(@sinon.com.tw
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Wheelchairs are the different batteries, and the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Inside the circle is a stylized emblem featuring three parallel lines that curve and flow, resembling a stylized representation of a human form or a symbol of interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2,0 2004
Sinon Corporation C/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K040319
Trade/Device Name: SINON Power Wheelchair, SN-W401 Regulation Number: 21 CFR 890.3860 Regulation Namc: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 28, 2004 Reccived: February 9, 2004
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. B r (2) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary to regars and the Medical Device Amendments, or to commerce prior to ritar 2011 - 11:15 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 r ou may, derere, misions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de looks o such 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 r reaso or awards 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 of any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 – Ke-Min Jen, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse of substantial equivalence of your device to a legally premance notification " 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 If you desire specific acrite for your 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
, Mark N. Milliken
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
4
Page_1_of _1
510 (K) NUMBER ( IF KNOW ):__ TBA DEVICE NAME: SINON Power Wheelchair, SN-W401_
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
Prescription Use OR Over-The-Counter-Use ✓
(Pef 21 CFR 80069) (Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040319
FI