(15 days)
Not Found
Not Found
Unknown
The term "Intelligent Posture and Purpose Adjustments (IPPA)" is used, which could imply some form of AI/ML, but the description lacks any technical details about how this "intelligence" is implemented or if it involves learning or complex algorithms. The "Not Found" entries for AI/ML mentions, training/test sets, and performance studies further contribute to the ambiguity.
No
The device is a multi-functional active wheelchair designed to increase functionality for individuals limited to a sitting position by allowing them to adjust their sitting posture. It does not appear to treat or prevent a medical condition.
No
The device is described as a multi-functional active wheelchair designed to increase functionality and adjust sitting posture, not to diagnose medical conditions.
No
The device description clearly identifies the device as a "Cat multi-functional active wheelchair," which is a physical hardware device. The description of the "IPPA" mechanism, while involving adjustments, is part of the physical wheelchair's functionality, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the "Cat multi-functional active wheelchair" is intended for use by individuals limited to a sitting position to increase their functionality and adjust their sitting posture. This is a physical assistive device used externally on the body, not for analyzing biological samples.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers, diseases, or conditions.
- Using reagents or laboratory procedures.
Therefore, the Cat multi-functional active wheelchair is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Cat multi-functional active wheelchair manufactured by movingpeople.net is intended for users by person(s) limited to a sitting position. It is designed to increase functionality for the person(s) by person(s). The Cat was designed to increase functionality. The most natural postures and movements that people use during the day, have been analyzed, described and resulted in a mechanism that is individually adjusted. This is know as the IPPA. IPPA stands for Intelligent Posture and Purpose Adjustments. It means that you can get a mechanism with which you can change your sitting posture in a second into the best desired position.
Product codes
IOR
Device Description
The Cat multi-functional active wheelchair manufactured by movingpeople.net is intended for users by person(s) limited to a sitting position. It is designed to increase functionality for the person(s) by person(s). The Cat was designed to increase functionality. The most natural postures and movements that people use during the day, have been analyzed, described and resulted in a mechanism that is individually adjusted. This is know as the IPPA. IPPA stands for Intelligent Posture and Purpose Adjustments. It means that you can get a mechanism with which you can change your sitting posture in a second into the best desired position.
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Movingpeople.net c/o Mr. Mark Job 510(k) Program Manager TÜV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112
MAR 2 1 2002
Re: K020737
Trade/Device Name: CAT Active Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 5, 2002 Received: March 6, 2002
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. 9 re(s) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978) in occordance with the provisions of the Federal Food, Drug, de necs that have been receases of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controll provisions of ractice, 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 is classinod controls. Existing major regulations affecting your device can mary of Sablet to Sack as alon a would be marts 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 i lease be actived that i Dr o retion that your device complies with other requirements of the Act that I Drimas made a comd regulations administered by other Federal agencies. You must or uny I vathar bather act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 607); adoming (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic rord in and quinty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Mark Job
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 premarket notification. The FDA mianing of casification 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 and If you desire specific advice for your devices diagnostic devices), please contact the Office of additionally 21 CI K Far 807.10 for questions on the promotion and advertising of Compliance at (301) 594-4637. The Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). It gulation cultured, "Misonanaing of roomsibilities under the Act may be obtained from the Other general information on your responsional 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
2
Page
510(k) Number (if known): K 0207377
Device Name: Cat
Indications For Use:
The Cat multi-functional active wheelchair manufactured by movingpeople.net is intended for frs by person(s) limited to a sitting position. It is designed to increase functionality for the person(s) by person(o) in The Cat was designed to increase functionality. The most natural postures and movements that people use during the day, have been analyzed, described and resulted in a mechanism that is individually adjusted. This is know as the IPPA. IPPA stands for Intelligent Posture and Purpose Adjustments. It means that you get a mechanism with which you can change your sitting posture in a second into the best desired position.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109) or
for Mark N. Millaras
Division of General, Restorative and Neurological Devices
510(k) Number_
SKST
Over-The-Counter Use
(Optional format 1-2-96)
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