(33 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a standard power wheelchair with manual controls. There is no mention of AI, ML, or any features that would suggest autonomous navigation, predictive maintenance, or other AI-driven functionalities.
No.
The device is a mobility aid for persons restricted to a seated position, not a device that provides therapy or treatment for a disease or condition.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device is a power wheelchair, intended to provide mobility, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Powered Wheelchair" with a physical base, wheels, seat, and battery, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "providing mobility to persons restricted to a seated position." This is a physical function, not a diagnostic one.
- Device Description: The description details a "Powered Wheelchair" with features related to mobility, control, and transport. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document lacks any of the typical characteristics of an IVD, such as:
- Mention of analyzing biological samples (blood, urine, tissue, etc.)
- Mention of detecting or measuring substances in the body
- Mention of diagnosing, monitoring, or predicting disease
The device described is a medical device, specifically a powered wheelchair, intended for providing physical assistance and mobility.
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 (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Home Health Power Wheelchair, HC-200TR 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, the seat can be tilted and reclined, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K04 3376 1/2
HOME HEALTH TECHNOLOGY CO., LTD.
NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C. JAN | 0 2005 Tel: 886-4-24914315 Fax: 886-4-24914401 E-mail: info@homehealth.com.tw http://www.homehealth.com.tw
દ્ધ 510(k) SUMMARY "
Submitter's Name: Home Health Technology Co., Ltd.
NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C.
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
Home Health Power Wheelchair, HC-200TR Powered Wheelchair Powered Wheelchair, Class II,
November 27, 2004
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 Home Health Power Wheelchair, HC-200TR 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, the seat can be tilted and reclined, 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-P401 (K040320)
1
KC433 76 2/2
HOME HEALTH TECHNOLOGY CO., LTD. NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C. Tel: 886-4-24914315 Fax: 886-4-24914401 E-mail: info@homehealth.com.tw http://www.homehealth.com.tw
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 removable armrest type, same casters size, same incline, 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 25 miles and 20 miles for the predicate device. This is mainly due to the fact that the batteries for the two 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 5 mph and 4 mph for the predicate device. Higher speed means the new device shall meet relevant requirements for the 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, seat dimensions, and weight limit. Besides the seat of the new device can be tilted and reclined. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
JAN 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jen. Ke-Min C/o Roc Chinese-European Industrial Research Society No.58, Fu-Chun ST. HSIN-CHU CITY, Taiwan, ROC
Re: K043376
Trade/Device Name: HOME HEALTH Power Wheelchair, HC - 200TR Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: November 27, 2004 Received: December 8, 2004
Dear Dr. Ke-Min:
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
Page 2 - Dr.Jen Ke-Min
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 (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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
Indications for Use
510 (K) Number ( If Known ): __ KO4337 6
Device Name: HOME HEALTH Power Wheelchair, HC-200TR
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 V
(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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of _1
510(k) Number K043376