(83 days)
Not Found
No
The summary describes a manual wheelchair with an electric standing function and does not mention any AI/ML terms or functionalities.
No
The device primarily aids in mobility and changing position, which are assistive and ergonomic functions, not direct therapeutic interventions for a medical condition.
No
The device description indicates it is a wheelchair designed to assist with mobility and positioning (sitting, standing, reclining), which are therapeutic or assistive functions, not diagnostic. The performance studies mention a standard for electrically powered wheelchairs, further supporting its classification as an assistive device.
No
The device description clearly states it is a wheelchair with an electric power standing mechanism, indicating it is 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/Indications for Use: The description clearly states the device's purpose is to change a person's position (sitting to standing, standing to sitting, reclining, lifting) and provide indoor/outdoor mobility. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a wheelchair with an electric standing mechanism. This is a mechanical/electrical device for physical support and movement.
- 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a mobility aid with a standing function, which falls under the category of medical devices that provide physical support and assistance, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
The COMFORT Standing Wheelchair is an indoor / outdoor standup wheelchair that is manual wheelchair, not an electric power wheelchair, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.
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
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
0
MFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No. 120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi, 60858, Taiwan, R.O.C. TEL : 886-5-2892093 FAX : 886-5-2890070
ર ૮ 510(k) SUMMARY "
DEC 1 4 2010
Submitter's Name: COMFORT ORTHOPEDIC CO., LTD.
N0. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, 60858, TAIWAN, ROC
Date summary prepared:
August 23, 2010
Device Name:
Proprietary Name: CQMFORT Standing Wheelchair, HERO series Common or Usual Name: Standup Wheelchair Classification Name: WHEELCHAIR, STANDUP, Class II, 21 CFR 890.3900
Product code:
COMFORT Standing Wheelchair, HERO series including:
IPL
- LY-ESA120 (HERO 3), .
- LY-ESA120-N (HERO 3-N).
All of the specifications are same as LY-ESA120 (HERO 3) just different headrest.
. LY-ESA140 (HERO 4)
All of the specifications are same as LY-ESA120 (HERO 3 ) but made by steel for the frame; and the HERO 3 and HERO 3-N are made by aluminum.
Indications for Use:
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility
Description of the device:
The COMFORT Standing Wheelchair is an indoor / outdoor standup wheelchair that is manual wheelchair, not an electric power wheelchair, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.
1
OMFORT COMFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei Shang,Chia-yi, 60858, Taiwan, R.O.C. TEL:886-5-2892093 FAX : 886-5-2890070
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:
COMFORT Standing Wheelchair, HERO 2 (K031618)
Summary for substantial equivalence comparison:
Compare to the new device and predicate device, the overall dimensions and visional appearance are similar, and the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Moreover, the suspension of cross brace, footplates, incline degree 12°, armrest type, the size of tires, the weight limit, and warranty are all the same. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.
Besides, we would like to emphasize that the new device and predicate device are also the Standing Wheelchairs which are the manual wheelchair, not the electric power wheelchairs, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.
Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor 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 (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Comfort Orthopedic Co., LTD % Mr. Eric H. C. Lee No. 120. Nan Shiang Tsuen Shoei Shang Shiang Chia-Yi 60858, Taiwan, R.O.C.
DEC 1 4 2010
Re: K102734
Trade/Device Name: COMFORT Standing Wheelchair, HERO series Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: September 30, 2010 Received: Ocotber 6, 2010
Dear Mr. Lee:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Eric H. C. Lee
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1138007.blog for for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Q: www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
AZ B. Rh
p.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ):
DEC 1 4 2010
Device Name: COMFORT Standing Wheelchair, HERO series
Intended Use:
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
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)
__, and I am not sure what to do with it.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102734