(105 days)
Not Found
No
The description explicitly states the device is "controlled, steered and operated completely by a trained caregiver" and mentions no AI/ML components or functionalities.
No
The device is described as an "Electric Transport Chair" intended to "transport patients," which indicates a mobility aid rather than a device for treating a medical condition.
No
The device's intended use is to transport patients; it does not collect, analyze, or interpret data to diagnose conditions.
No
The device description clearly outlines a physical, motorized transport chair with batteries, wheels, and hand-operated controls, indicating it is a hardware device, not software-only.
Based on the provided information, the BREEZ Electric Transport Chair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "transport patients within acute, alternative and long term care facilities." This is a physical function related to patient mobility, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a motorized chair for transporting patients, focusing on its mechanical and electrical components. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD-related information: The document does not contain any of the typical characteristics of an IVD submission, such as:
- Mentions of image processing, AI, DNN, or ML (which can be used in some IVDs).
- Input imaging modality (relevant for some diagnostic devices).
- Anatomical site (relevant for where a sample is taken or a test is performed).
- Description of training or test sets for diagnostic algorithms.
- Performance studies focused on diagnostic metrics like sensitivity, specificity, AUC, etc.
The device is clearly a medical device intended for patient transport, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The BREEZ Electric Transport Chair is a motorized device that allows caregivers to move patients up to 750 pounds in weight.
The device has self-contained batteries to provide power that can be recharged by an on-board battery charger that can be plugged into a 120/240 VAC outlet when the device is not in use. The device is supported by four wheels whereby the front wheels provide the motive force to propel the unit in either the forward or reverse direction. The caregiver directs the movement of the device using a steering handlebar and various hand-operated controls attached to the rear of the device.
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
The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.
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)
The BREEZ Electric Transport Chair was tested in accordance with the following voluntary standards.
CISPR 11 (Radiated/Conducted Emissions)
EN61000-4-2: 2008-10 Electrostatic Discharge
EN61000-4-3: 2008-4 Radiated Immunity Test
As required by FDA 's July 26, 1995, draft publication entitled "Guidance Document for the preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", dimensional, performance, and static tests were conducted according to RESNA WC-1: 2009 and RESNA WC-2: 2009.
In all instances, the BREEZ Electric Transport Chair met the required performance criteria and functioned as intended.
The seat material used on the BREEZ Electric Transport Chair conforms to the California Flammability Regulation (Bulletin 117, Section E).
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.
Heartway Attendant-Controlled Power Chair, TC1 (K071006)
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
AUG - 3 2011
Section 5-510(k) Summary
Date Prepared: July 23, 2011
Submitter: Electro Kinetic Technologies, LLC W194 N11301 McCormick Drive Germantown, Wisconsin 53022
- Contact: Raymond Erbe P.E. President Electro Kinetic Technologies, LLC W194 N11301 McCormick Drive Germantown. Wisconsin 53022 Phone: 262-250-7740 x400 Fax: 262-250-7741 Email: rerbe@ek-tech.com
Trade Name of Device: BREEZ 1025 Electric Transport Chair
Classification: Wheelchair, Powered Wheelchair - 21 CFR 890.3860
Class: Class II
Product Code: ITI
Predicate Device: Heartway Attendant-Controlled Power Chair, TC1 (K071006)
Intended Use
The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.
Device Description
The BREEZ Electric Transport Chair is a motorized device that allows caregivers to move patients up to 750 pounds in weight.
The device has self-contained batteries to provide power that can be recharged by an on-board battery charger that can be plugged into a 120/240 VAC outlet when the device is not in use. The device is supported by four wheels whereby the front wheels provide the motive force to propel the unit in either the forward or reverse direction. The caregiver directs the movement of the device using a steering handlebar and various hand-operated controls attached to the rear of the device.
1
Functional & Safety Testing
The BREEZ Electric Transport Chair was tested in accordance with the following voluntary standards.
CISPR 11 (Radiated/Conducted Emissions)
EN61000-4-2: 2008-10 Electrostatic Discharge
EN61000-4-3: 2008-4 Radiated Immunity Test
As required by FDA 's July 26, 1995, draft publication entitled "Guidance Document for the preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", dimensional, performance, and static tests were conducted according to RESNA WC-1: 2009 and RESNA WC-2: 2009.
In all instances, the BREEZ Electric Transport Chair met the required performance criteria and functioned as intended.
The seat material used on the BREEZ Electric Transport Chair conforms to the California Flammability Regulation (Bulletin 117, Section E).
Substantial Equivalence
The BREEZ Electric Transport Chair is substantially equivalent to the Heartway Attendant-Controlled Power Chair, TC1.
This device has the same intended use as the legally marketed device as shown in the substantial equivalence table, with technological characteristics that do not raise questions on the safety and effectiveness during use. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any questions as to the safety and effectiveness, therefore the BREEZ Electric Transport Chair is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. 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
Electro Kinetic Technologies, LLC % Mr. Raymond Erbe President W194 N11301 McCormick Drive Germantown, Wisconsin 53022
Re: K111095
Trade/Device Name: Breez Electric Transport Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 25, 2011 Received: July 28, 2011
AUG - 3 2011
Dear Mr. Erbe:
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 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
3
Page 2 - Mr. Raymond Erbe
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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.
Sincerely vours.
Sincerely yours,
Mark A. Millhiser
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
KI11095 510(k) Number (if known): Device Name: BREEZ CHAIR TRANSPORT ELECTRIC Indications For Use:
The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.
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, Offige of Device Evaluation (ODE)
signature
(Division Sign-Off) (Division Sign-On Sign-Onthopedic, and Restorative Devices
510(k) Number K111095
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