(84 days)
Not Found
No
The description focuses on basic powered wheelchair functionality controlled by hand controls and does not mention any AI/ML features.
No.
The device's intended use is to provide mobility, not to treat or cure a medical condition.
No
Explanation: The device is described as a powered wheelchair intended to provide mobility, not to diagnose medical conditions.
No
The device description clearly states it is a "Powered Wheelchair" with a physical base, wheels, seat, and hand controls, 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 seated position." This is a functional purpose related to physical assistance, not to diagnose, monitor, or treat a medical condition by examining specimens from the human body.
- Device Description: The description details a powered wheelchair, a device for mobility. It doesn't mention any 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 (IVDs often target specific body parts or systems)
- Description of training/test sets for diagnostic algorithms
- Performance studies focused on diagnostic metrics (Sensitivity, Specificity, etc.)
The performance studies mentioned (EMC Report and standards related to electrically powered wheelchairs) are relevant to the safety and functionality of a mobility device, not an IVD.
Therefore, the SOLEUS POWERED WHEELCHAIR, FAD-2 is 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 device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes
ITI
Device Description
The SOLEUS POWERED WHEELCHAIR, FAD-2 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)
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the batteries and recharge. Thus the same safety level for the two devices is assured. Besides, the foldable frame and back upholstery are the same material that also be passed the resistance ignition test by the SGS. The major differences existing of the two Powered Wheelchairs are the different overall dimension, and the sizes of tires are differences between the two devices. The overall appearance differences are not safety aspect. Besides the two devices use the different electric controllers but all passed by EN 12184, WC / Vol.2:1998, Radiated Immunity: 30 V/m. So the new device is substantially equivalent to the predicate devices in this aspect.
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
SOLEUS CHAMP INTERNATIONAL CO., LTD.
No.1-6, Kung Fu Rd., Liao Bao Village, Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, R.O.C. Tel: 886-4-2560-1853 Fax: 886-4-2560-1142 E-mail: kspeed97@ms27.hinet.net
MAR 1 4 2005
દ દ 510(k) SUMMARY "
Submitter's Name: SOLEUS CHAMP INTERNATIONAL CO., LTD.
No.1-6, Kung Fu Rd., Liao Bao Village,Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, R.O.C.
Date summary prepared:
December 9, 2004
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
SOLEUS POWERED WHEELCHAIR, FAD-2 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 SOLEUS POWERED WHEELCHAIR, FAD-2 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: TEH LIN POWERED WHEELCHAIR MDG-201 (K022696)
1
SOLEUS CHAMP INTERNATIONAL CO., LTD.
No.1-6, Kung Fu Rd., Liao Bao Village, Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, R.O.C. Tel: 886-4-2560-1853 Fax: 886-4-2560-1142 E-mail: kspeed97@ms27.hinet.net
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the batteries and recharge. Thus the same safety level for the two devices is assured. Besides, the foldable frame and back upholstery are the same material that also be passed the resistance ignition test by The major differences existing of the two Powered Wheelchairs are the SGS. different overall dimension, and the sizes of tires are differences between the two The overall appearance differences are not safety aspect. Besides the two devices. devices use the different electric controllers but all passed by EN 12184, WC / Vol.2:1998, Radiated Immunity: 30 V/m. So the new device is substantially equivalent to the predicate devices in this aspect.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
MAR 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Ke Min Jen Official Correspondence Soleus Champ International Co., LTD. No. 1-6, Kung Fu Rd., Liao Bao Village Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, ROC
Re: K043511
Trade/Device Name: Soleus Power Wheelchair, FAD-2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 27, 2005 Received: February 22, 2005
Dear Dr. Ke Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device is died in we nave leviewed your Section 910(x) prematitilly equivalent (for the indications for use stated in the above and have determined the devices marketed in interstate commerce prior to May 28, 1976, enclosure) to regarly marketod produce Amendments, or to devices that have been reclassified in the chacinent date of the Frederal Food, Drug, and Cosmetic Act (Act) that do not require accondited with the provisions of the PMA). You may, therefore, market the device, subject to approval of a premaince approvial approvince to the general controls provisions of the Act include the general controls pro risins of an i seing 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 may be If your device is elassified (soc above) into major regulations affecting your device can be found in the Subject to Suen additions, 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 of Statules and legalatons administered of other in the mand listing (21 CFR Part 807); labeling (21 CFR requirements, meruding, but not mines es virements as set forth in the quality systems (QS) regulation I all 601), good minutectaring product radiation control 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 5 I0(k) premarket This letter will allow you to begin marketing your device of your device to a legally market. notification. The FDA Inding of substantal equivalience 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 If you desire specific advice for your device on the regulation entitled, "Mishranding by the Office of Compliance at (240) 270-0120 . Yuso, production other general information on
reference to premarket notification" (21CFR Part 807.97). You may obtain other an reference to premiarket nonitation (21ct I F in Correst Small Manufacturers, International and your responsibilities under the Act from the Division of Shan Manada 44-47-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark Melbern
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
043511 510 (K) Number ( If Known ):_
Device Name: SQLEUS Power Wheelchair, FAD-2_
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted 1 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark. A. Millham
Page_ 1__of __1
Division of Genera , Restorative, and Neurological Devices
510(k) Number K043511