(312 days)
Not Found
No
The device description and performance studies focus on mechanical components and standard wheelchair testing, with no mention of AI or ML.
No.
The device's intended use is to provide mobility. While it is operated by pedaling, which involves physical activity, the primary purpose is transportation, not therapy. It does not mention any therapeutic claims or functions.
No
Explanation: The device is described as a manually operated and driven wheelchair used to provide mobility, not to diagnose medical conditions. Its purpose is transportation, and the performance studies focus on mechanical standards and safety, not diagnostic accuracy.
No
The device description clearly details a physical wheelchair with mechanical components (chassis, pedaling mechanism, wheels, casters, seat, back, brakes, handle bars). There is no mention of any software component.
Based on the provided information, the Profhand pedal wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to persons with the capability of operating a mechanical wheelchair. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a mechanical wheelchair with a pedaling mechanism, brakes, wheels, and seating. It describes a device for physical transportation and mobility.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the mechanical aspects of the wheelchair, such as stability, brake effectiveness, dimensions, and material properties, not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Profhand pedal wheelchair does not fit this definition.
N/A
Intended Use / Indications for Use
Profhand pedal mechanical wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
Profhand pedal wheelchair is manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time
For the main construction of HM-10 wheelchair, please see the following detailed description: The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion and back are made from flame retardant Nylon and/or Polyester fabric.
The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device):
- Put a suitable seat cushion on the wheelchair seat.
- Put your foot into the pedal and attach the foot strap to stabilize foot.
- When riding use both legs to pedal for forward movement.
- To stop use the brake mounted in the control lever.
- For parking or getting on/off the wheelchair lock the brakes
In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.
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)
Profhand pedal wheelchair/Model HM-10 have been designed, manufactured and tested for conformance to the relevant FDA recognized ISO standards for mechanical wheelchair as referenced in this submission. In addition, Profhand pedal wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motonzed Three-Wheeled Vehicles.
Compliance testing to FDA recognized standards includes the following list:
-
- ISO 7176-1: 1999 Determination of static stability.
-
- ISO 7176-3; 2003 Determination of effectiveness of brake.
-
- ISO 7176-5; 2008 Determination of overall dimensions, mass, and maneuvering space.
-
- ISO 7176-11: 1992 Test dummies.
-
- ISO 7176-13; 1989 Determination of coefficient of friction of test surface.
-
- ISO 7176-15; 1996 Requirement for information disclosure, documentation and labeling.
-
- ISO 7176-16: 1997 Resistance to ignition of upholstered parts.
-
- ISO 10993-1; 2009- Guidance on selection of biocompatibility tests.
-
- ISO 10993-5; 2009- Biocompatibility tests for cytotoxicity in vitro method.
-
- ISO 10993-10: 2009 Biological tests for irritation and delayed-type hypersencitivity.
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.
Panthera Mechanical wheelchairs / Model S2 (K083231)
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
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Harmony Hill International Co., Ltd.
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K123076 .
AUG 0 9 2013
Date of Summary prepared: July 22, 2013
- Harmony Hill International Co., Ltd. 1. Submission Correspondent:
Address:
Rm. 1068, 10F, H bldg. of NKSP, No. 3-2,
Park St., Nangang Dist., Taipei, Taiwan
Phone:
Fax:
Contact:
Mrs Tina Lai
+886-2-2655-7717
+886-2-2655-7715
Harmony Hill International Co., Ltd. Rm. Submission Sponsor: 1068, 10F, H bldg. of NKSP, No. 3-2, Park St., Nangang Dist., Taipei, Taiwan Tel +886-2-2655-7717 Fax +886-2-2655-7715 E-mail tina@hhic.com.tw
- Date Prepared:
Trade Name(s): 4.
Common/Usual Name: Classification Name: Classification Number: Classification Panel: CDRH Product Code: Requlatory Class:
May 25, 2013
Profhand Pedal Wheelchair Models HM-10 Mechanical Wheelchair Wheelchair, Mechanical 890.3850 Physical Medicine Devices IOR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Device Description
Profhand pedal wheelchair is manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time
For the main construction of HM-10 wheelchair, please see the following detailed description: The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion
1
Harmony Hill International Co., Ltd.
and back are made from flame retardant Nylon and/or Polyester fabric.
The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device):
- · Put a suitable seat cushion on the wheelchair seat.
- · Put your foot into the pedal and attach the foot strap to stabilize foot.
- · When riding use both legs to pedal for forward movement.
- · To stop use the brake mounted in the control lever.
- · For parking or getting on/off the wheelchair lock the brakes
In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.
6. Intended Use
Profhand pedal mechanical wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
7. Predicate Devices
Panthera Mechanical wheelchairs / Model S2 (K083231)
8. Safety and Effectiveness
By definition. the HM-10 device is substantially equivalent to a predicate device because the device has the same intended use and different technological characteristics. The main technology difference is that for our HM-10 wheelchair, the device provide mobility to person restricted to a sitting position either by attendant via using rear handle bar or by himself via using leg-pedalinq mechanism, but for the predicate Panthera wheelchair, the device provide mobility to person restricted to a sitting position either by attendant via using rear handle bar or by himself via using hand-pedaling mechanism.
Through the rationale justification, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
As such, it has been shown in this 510(K) submission, that the differences between the Profhand pedal wheelchair/Model HM-10 and the predicate devices, the Panthera Mechanical wheelchair (ref K083231), do not raise any questions regarding their safety and effectiveness.
2
9. Performance Date
Profhand pedal wheelchair/Model HM-10 have been designed, manufactured and tested for conformance to the relevant FDA recognized ISO standards for mechanical wheelchair as referenced in this submission. In addition, Profhand pedal wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motonzed Three-Wheeled Vehicles.
Compliance testing to FDA recognized standards includes the following list:
-
- ISO 7176-1: 1999 Determination of static stability.
-
- ISO 7176-3; 2003 Determination of effectiveness of brake.
-
- ISO 7176-5; 2008 Determination of overall dimensions, mass, and maneuvering space.
-
- ISO 7176-11: 1992 Test dummies.
-
- ISO 7176-13; 1989 Determination of coefficient of friction of test surface.
-
- ISO 7176-15; 1996 Requirement for information disclosure, documentation and labeling.
-
- ISO 7176-16: 1997 Resistance to ignition of upholstered parts.
-
- ISO 10993-1; 2009- Guidance on selection of biocompatibility tests.
-
- ISO 10993-5; 2009- Biocompatibility tests for cytotoxicity in vitro method.
-
- ISO 10993-10: 2009 Biological tests for irritation and delayed-type hypersencitivity.
10. Conclusion
Profhand pedal wheelchair/Model HM-10 as designed and manufactured is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the predicate devices, the Panthera Mechanical wheelchair (ref K083231).
3
Image /page/3/Picture/0 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 a stylized symbol that resembles three abstract shapes, possibly representing human figures or abstract forms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2013
Harmony Hill International c/o Ms.Tina Lai Room 1068, 10F, H Bldg. of NKSP, NO.3-2 Park Street, Nangang Dist Taipei China (Taiwan) 11503
Re: K123076
Trade/Device Name: Profhand Pedal Wheelchair Model HM-10 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 2, 2013 Received: June 5, 2013
Dear Ms. Tina Lai:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Ms. Tina Lai
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
for
Sincerely yours.
Joyce M. Whang -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K123076
Device Name: Profhand Pedal Wheelchair Model HM-10
Indications For Use:
Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number_K123076
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