(61 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard powered wheelchair and does not mention any AI or ML capabilities. The performance studies reference a 1995 guidance document, further suggesting a lack of advanced software features.
No
The device is a powered wheelchair for transportation; it does not treat or prevent a medical condition, which are characteristics of a therapeutic device.
No
Explanation: The device description states that the C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair for transportation, and the intended use confirms it provides transportation for disabled or elderly persons. There is no mention of diagnostic capabilities, imaging, or analysis of physiological data.
No
The device description clearly states it is a "powered wheelchair" with physical components like wheels, a seat, and a controller, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The C.T.M. Power Chair HS-1500 is clearly described as a powered wheelchair for transportation. Its function is to provide mobility for disabled or elderly individuals. It does not involve the analysis of biological specimens.
The provided information about the device's function, design, and testing all point to it being a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person.
Product codes
89ITI
Device Description
The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a controller attached to one armrest which allows the rider to control the movement of the chair. It can be disassembled for transport and is provided with an on-board battery charger.
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)
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission. Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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 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
510(k) SUMMARY
FES 27 - -
| Submitter's name: | C.T.M. Homecare Product, Inc. |
|---|---|
| 13825 Norton Ave., Chino, CA 91710 |
Linda J. Bovard, Bovard Consulting, LLC, Eugene, OR Contact name: (541) 345-5431
Date summary prepared: December 24, 2007
Device name:
Proprietary name: C.T.M. Power Chair HS-1500 Common or usual name: Power chair Classification name: Powered wheelchair (890.3860). Powered wheelchair (89 ITI)
Legally marketed device for substantial equivalence comparison:
The predicate device for this submission is the Alanté submitted by Golden Technologies, Inc. and cleared for marketing under 510(k) *K011153.
Description of the device:
The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a controller attached to one armrest which allows the rider to control the movement of the chair. It can be disassembled for transport and is provided with an on-board battery charger.
Intended use of device:
The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person.
Technological characteristics:
The device features of the C.T.M. Power Chair HS-1500 and the Alanté are very similar. Both are battery operated, have two motors, and have automatic braking systems. Battery chargers are provided with both wheelchairs, but the HS-1500 charger is onboard. Both power chairs can be disassembled for transport, but the HS-1500 does not require any tools. The target population is identical and the use parameters are similar.
Testing conducted:
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
FEB 2 7 2008
Food and Drug Administration
Public Health Service
C.T.M Homecare Product, Inc. % Bovard Consulting, LLC Ms. Linda J. Bovard President 29611 Simmons Road Eugene, Oregon 97405
Re: K073686
Trade/Device Name: C.T.M. Power Chair HS-1500 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: 89ITI Dated: December 24, 2007 Received: December 28, 2007
Dear Ms. Bovard:
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 such 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); 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.
9200 Corporate Boulevard Rockville MD 20850
2
Page 2 - Ms. Linda J. Bovard
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 marketed predicate device results in a classification 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Mulhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
C.T.M. Power Chair HS-1500 510(k) Notification
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: C.T.M. Power Chair HS-1500
Indications for Use:
The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R
Division Sign-Off) l Vivision of General, Restorative, and Neurological Devices
10(k) Number
16736 YL