(126 days)
Not Found
No
The description focuses on basic mechanical and electrical components and control via hand controls, with no mention of AI or ML terms or functionalities.
No.
The device provides mobility, which is a supportive function, rather than an active treatment or therapy for a medical condition.
No
The device is a power wheelchair, which is a mobility aid, not a diagnostic tool. Its intended use is to provide mobility, and there is no mention of it being used to detect, diagnose, or monitor any medical condition.
No
The device description clearly describes a physical, battery-operated power wheelchair with a 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 the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a "Powered Wheelchair" with components like a base, wheels, seat, hand controls, and a battery. This aligns with a mobility aid, not a device used for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
The performance testing mentioned (EMC Report, ANSI/RESNA standards) is also relevant to the safety and functionality of a mobility device, not the analytical performance of an IVD.
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 Home Health Power Wheelchair, HC-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 (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)
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
FEB - 3 2005
દર 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: | September 27, 2004 |
|---|---|
| Device Name: | |
| Proprietary Name: | Home Health Power Wheelchair, HC-200 |
| Common or Usual Name: | Powered Wheelchair |
| Classification Name: | 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 Home Health Power Wheelchair, HC-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 their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
SINON Power Wheelchair, SN-P401 (K040320)
1
HOME HEALTH TECHNOLOGY CO., LTD. NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C. Fax: 886-4-24914401 Tel: 886-4-24914315 http://www.homehealth.com.tw E-mail: info@homehealth.com.tw
Summary for substantial equivalence comparison:
.
ﺩﻏﻪ ﺩ ﺩﻏﻪ ۱۰ ﺩ
The electronic systems between two devices are the same suppliers 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 limit 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
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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. There is a number "0" at the bottom of the image.
Public Health Service
FEB - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Home Health Technology Co., LTD. C/o Dr. Ke-Min Jen C/o Dr. RC-Mini John Industrial Research Society No.58, Fu-Chun ST. HSIN-CHU CITY, Taiwan, ROC
Re: K042719
K042719
Trade/Device Name: HOME HEALTH Power Wheelchair, HC – 200 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 20, 2005 Received: January 27, 2005
Dear Dr. Ke-Min:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(K) premarket is substantially equivalent (for the indications for referenced above and have determined the devices marketed in interstate comments.
use stated in the enclosure) to legally market of Malice Mexicos Americas that use stated in the enclosure) to legally inate collect Device Amendments, or to devices that prior to May 28, 1976, the enactlient with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features in have been reclassified in accordance will the provisions of wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval applications of t Act (Act) that to not require apploval of a prematics apple moreisions of the Act. The general
therefore, market the device, subject to the general courses proxistions of dev therefore, market the device, subject to me generation, listing of devices, good
controls provisions of the Act include requirements for annial registration, listing of devic controls provisions of the Act melude requirements for and adulteration.
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 If your device to such additional controls. Existing major regulations affecting your device can be
may be subject to such additional controls. Title All Redditions FDA may may be subject to such additions, "İxle 21, Parts 800 to 89% In addition, FDA may publish
found in the Code of Federal Regulations, "Title 21, Parts 800 to 89% In additi found in the Code of I caeral migg your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that HDA s Issualice of a subscription with other requirements of the Act or any
FDA has made a determination that your device complex . You must comply wit FDA has made a determination that your device only researces. You must comply with all
Federal statutes and regulations administerial by other condition (1) CFR Part 807): Federal statutes and regulations administered by other registration and listing (21 CFR Part 807);
the Act's requirements, including, but not limited to: registration as as a the Act's requirements, including but not unnited to requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing proctice requirements as set fort labeling (21 CFR Part 801); good manufacturing (nactive station in and control
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation systenis (QB) rogalaton (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,
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 ):
Device Name: HOME HEALTH Power Wheelchair, HC-200
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use Over-The-Counter Use AND/OR
(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 K042719
F