(154 days)
Not Found
No
The description focuses on mechanical and electrical components for mobility and standing, with no mention of AI or ML technologies for control, analysis, or decision-making.
Yes
The device is intended to assist pediatric patients with various disabilities to independently ambulate, which addresses a physiological need and provides therapeutic benefit by promoting mobility and standing.
No
Explanation: The provided text describes a power standing wheelchair, which is a mobility device designed to assist pediatric patients with ambulation. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly details physical components such as wheels, motors, batteries, a frame, prone board, and standing platform, indicating it is a hardware device with integrated power and control systems, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Power Standing Dani stand-up wheelchair is a mobility device. Its purpose is to assist pediatric patients with disabilities in standing and ambulating.
- No Biological Samples: There is no mention of the device interacting with or analyzing any biological samples from the patient.
- Physical Support and Movement: The device provides physical support and enables movement, which are characteristics of a medical device but not an IVD.
Therefore, the Power Standing Dani stand-up wheelchair falls under the category of a medical device (specifically, a mobility aid), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Power Standing Dani stand-up wheelchair is a sit to stand mobility device equipped with power driven rear mounted wheels intended for the pediatric population with disabilities which limits their ability to ambulate without assistance. The product is designed for indoor/outdoor use on normal pedestrian terrain such as asphalt, grass, and gravel and not indicated for slopes exceeding 6° in a downhill, uphill or lateral orientation. The device is not intended for use while being transported in a moving vehicle.
The Power Standing Dani stand-up wheelchair (wheelstand) is a sit to stand mobility device equipped a removable prone board and standing platform with a joystick controlled power driven rear mounted wheels, providing the pediatric population with disabilities the providing the pocking to independently ambulate in the standing position. Types of disability diagnosis include spina bifida, cerebral palsy, muscular dystrophy, spinal muscular atrophy, spinal cord injury, and various other neurological disorders.
Product codes
IPL
Device Description
The Power Standing Dani stand-up wheelchair (wheelstand) is equipped with a vertical positioning prone board with an attached standing platform, inclined slightly forward, to which the pediatric is supported with lateral, anterior and posterior components in the upright position. The prone board and standing platform are comprised of positioning components that are interchangeable and whose location can be adjusted to accommodate the precise needs for each individual. The prone board and attached standing platform are securely mounted to an adjustable steel base frame, to which the power driven rear wheels and front suspension caster wheels are mounted.
The drive power is provided through a rear mounted wheel system, branded as the e-fix® is supplied by Ulrich Alber. Gmbh. Each of the two drive wheels contains a 110 Watt motor, brake and gear box in its hub. The wheels sizes are available in 12" or 24" diameter. The wheel motors are powered with 2x12V (12Ah or 17Ah) batteries, which are secured in a solid mounting rack. Front suspension castor wheels support the front of the frame and allow indirect steering by applying differential power to the rear drive wheels through the joystick controller.
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
pediatric population
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)
Not Found
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
§ 890.3900 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
JUL - 6 2009
DavisMade, Inc.
510(k) Submission: Power Standing Dani
510(K) SUMMARY
Submitter:
DavisMade, Inc. 2511 Davison Rd. Flint, MI 48506 810-233-9706 (Phone) 810-233-9716 (Fax) info@standingdani.com (e-mail)
FDA Registration #: 1833039
Daniel Davis Contact Person:
27 January 09 Preparation Date:
Proprietary name: Power Standing Dani
Electric Power Wheelchair, Stand-up Classification Name:
Regulatory Class: Class II
Product Code: IPL
Identification of Predicate Devices: Lifestand - LSC Lifestand (K041535) DavisMade Standing Dani (K890602) Ulrich Alber e-fix ® power add-on (K041535)/
Intended Use: The Power Standing Dani stand-up wheelchair is a sit to stand mobility device equipped with power driven rear mounted wheels intended for the pediatric population with disabilities which limits their ability to ambulate without assistance. The product is designed for indoor/outdoor use on normal pedestrian terrain such as asphalt, grass, and gravel and not indicated for slopes exceeding 6° in a downhill, uphill or lateral orientation. The device is not intended for use while being transported in a moving vehicle.
Device Description:
The Power Standing Dani stand-up wheelchair (wheelstand) is equipped with a vertical positioning prone board with an attached standing platform, inclined slightly forward, to which the pediatric is supported with lateral, anterior and posterior components in the upright position. The prone board and standing platform are comprised of positioning components that are interchangeable and whose location can be adjusted to accommodate the precise needs for each individual. The prone board and attached standing platform are securely mounted to an adjustable steel base
1
510(k) Submission: Power Standing Dani
DavisMade, Inc.
frame, to which the power driven rear wheels and front suspension caster wheels are mounted.
The drive power is provided through a rear mounted wheel system, branded as the e-fix® is supplied by Ulrich Alber. Gmbh. Each of the two drive wheels contains a 110 Watt motor, brake and gear box in its hub. The wheels sizes are available in 12" or 24" diameter. The wheel motors are powered with 2x12V (12Ah or 17Ah) batteries, which are secured in a solid mounting rack. Front suspension castor wheels support the front of the frame and allow indirect steering by applying differential power to the rear drive wheels through the joystick controller.
Safety and Effectiveness: The Power Standing Dani was developed based on extensive knowledge and experience gained by providing standing mobility for pediatrics requiring assistive technology since the introduction of the Manual Standing Dani® in 1990. This knowledge and experience has shown prone standing with adjustable support systems, allows the pediatrics optimum psychological and physiological benefits.
The manually propelled Standing Dani, however, is not intended for those pediatrics with restrictive strength and physical attributes that limit their ability to be independently mobile. The addition of a safe and effective joy stick controlled power drive add-on provides that pediatric population the same psychological and physiological benefits as those capable of manually selfpropelling.
The Power Standing Dani utilizes the identical prone board and standing platform as the Manual Standing Dani and incorporates an FDA cleared wheelchair power add-on conversion kit.
ii
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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DavisMade, Incorporated % Mr. Daniel W. Davis Chief Executive Officer & Founder 2511 Davison Road Flint, Michigan 48506
Re: K090256
Trade/Device Name: The Power Standing Dani Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: April 17, 2009 Received: June 16, 2009
Dear Mr. Davis:
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.
JUL - 6 2009
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
3
Page 2-Mr. Daniel W. Davis
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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Submission: Power Standing Dani
DavisMade, Inc.
STATEMENT OF INDICATIONS FOR USE
510(k) Number: (If known)
Indications for use:
The Power Standing Dani stand-up wheelchair (wheelstand) is a sit to stand mobility device equipped a removable prone board and standing platform with a joystick controlled power driven rear mounted wheels, providing the pediatric population with disabilities the providing the pocking to independently ambulate in the standing position. Types of disability diagnosis include spina bifida, cerebral palsy, muscular dystrophy, spinal muscular atrophy, spinal cord injury, and various other neurological disorders.
Proprietary name:
Power Standing Dani
Prescription Use
Over-The Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
XX
Lawrence D. Taylor
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090256