(62 days)
Not Found
No
The description focuses on basic powered wheelchair functionality controlled by hand controls, with no mention of AI/ML terms or capabilities.
No
The device provides mobility support rather than treating a medical condition or restoring a bodily function.
No
The device description clearly states it is a power 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, and hand controls, indicating it is a hardware device.
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 seated position. This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a powered wheelchair, which is a mobility aid. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
Therefore, based on the provided information, the PRO WALKER Power Wheelchair, PL-200 is a mobility device and not an In Vitro Diagnostic.
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 PRO WALKER Power Wheelchair, PL-200 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 the chargers - requirements and test methods)
Key Metrics
Not Found
Predicate Device(s)
SINON Power Wheelchair W401 (K040319)
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
May 11, 2004
JUL 2 0 2004
Image /page/0/Picture/2 description: The image shows the logo and contact information for Pro Walker Inc. The logo includes the company name and a stylized letter 'P' with wave-like lines inside. The contact information includes the company's address at No. 60, An Li Lane, Chang An Rd., Tachia, Taichung Hsien, TAIWAN, R.O.C., as well as their phone number (+886-4-2682-1799), fax number (+886-2682-1899), website (www.pro-walker.com.tw), and email address (pro.walker@msa.hinet.net).
દ ( 510(k) SUMMARY "
Submitter's Name: PRO WALKER INC.
No. 60, An Li Lane, Chang An Roud, Tachia, Taichung Hsine, Taiwan, 437, ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
PRO WALKER Power Wheelchair, PL-200 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 PRO WALKER Power Wheelchair, PL-200 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 the chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
SINON Power Wheelchair W401 (K040319)
1
Image /page/1/Picture/0 description: The image shows a logo with the text "PRO WALKER" below a stylized letter "P". The "P" has a thick, bold design with a horizontal line through the upper part, creating a wave-like shape within the letter. The text "PRO WALKER" is in a simple, sans-serif font, with "PRO" above "WALKER".
. 60. An Li Lane, Chang An Rd., Tachia, Taichung Hsien. TAIWAN. R.O.C Fax: +886-2682-1899 Tel: +886-4-2682-1799 Website: www.pro-walker.com.tw E-mail : pro.walker@msa.hinet.net
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
We can know from the above table that the intended use between two devices is the The batteries used are the same brand and similar U1 type. The control same. systems for the two devices are used from same brand and different types: Dynamic SHARK for the new device, and Dynamic DL for the predict device. The recharge for the two devices are also used the same supplier, and the chargers are also certified by UL. Besides, the foldable frame, removable armrest type, same weight limit, and back upholstery are the same material that also be passed the resistance ignition test by SGS.
The cruising range of the new device is 20~25 miles and 20 miles for the predicate device. This is mainly due to the fact that the batteries for the predicate devices are smaller. Certainly the real range depends on the practice environments. i.e., weight. surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
The maximum speed for the new device is 4.7 mph and 4 mph for the predicate Higher speed means the predicate device shall meet relevant requirements for the device. braking time, distance, and dynamic stability for safety considerations. The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect.
To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, and seat dimensions. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices 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 decide the subject device and the predicate device are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of 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.
JUL 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pro Walker, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K041336
Trade/Device Name: PRO WALKER Power Wheelchair, PL-200 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 24, 2004 Received: June 2, 2004
Dear Dr. Jen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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'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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
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__________________________________________________________________________________________________________________________________________________________________________
510 (K) NUMBER ( IF KNOW ): ___TBA ___________________________________________________________________________________________________________________________________________ DEVICE NAME: PRO WALKER Power Wheelchair, PL-200 -
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)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K041336 |
|---|---|
| --------------- | --------- |