(14 days)
Not Found
No
The summary describes a standard mechanical wheelchair with no mention of AI or ML features.
No
A therapeutic device is used to treat or manage a medical condition. A wheelchair primarily provides mobility assistance and does not directly treat a medical condition.
No
Explanation: The device is a mechanical wheelchair, which is used for mobility and not for diagnosing medical conditions.
No
The device description clearly states it is a "mechanical wheelchair" with physical components like wheels and a seat, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "mechanical wheelchair" used for "providing mobility to persons limited to a sitting position." This is a physical mobility aid, not a device that performs tests on biological samples.
- Intended Use: The intended use is for mobility, not for diagnosing or monitoring a medical condition through testing of samples.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing biological samples
- Detecting biomarkers or analytes
- Performing laboratory tests
- Any components typically found in IVD devices (reagents, analyzers, test strips, etc.)
Therefore, based on the provided information, the AIR, Inc. Model "Flight" mechanical wheelchair is a mobility device and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.
Product codes
IOR
Device Description
The AIR, Inc. Model "Flight" mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The device can be easily folded for transport.
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)
The "Flight" mechanical wheelchair meets the applicable voluntary ANSI/RESNA standards for mechanical wheelchairs. The upholstery meets ANSI/RESNA WC Volume 1, Section 16: Determination of flammability.
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.
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
Ko6//86
510(k) Summary MAY 12 2006 of Safety and Effectiveness
GENERAL INFORMATION A.
| 1. Submitter's Name: | Aero Innovative Research, Inc. | |
|---|---|---|
| -- | ---------------------- | -------------------------------- |
-
- Address:
- Contact Person:
Date prepared:
- Registration Number:
500 W. Clay Street Valley Center, KS 67147 Matt Cochran March 6, 2006 Applied For
B. DEVICE
| 1. Proprietary or Trade Name: | Flight |
|---|---|
| 2. Common Name: | Mechanical Wheelchair |
| 3. Classification Name: | Wheelchair, Mechanical |
| 4. Classification Panel: | Physical Medicine |
| 5. Product Code(s): | IOR |
| 6. Class for New Device: | Class I |
| 7. Regulation Number: | 890.3850 |
C. INDICATIONS FOR USE
Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.
DESCRIPTION OF THE DEVICE D.
The AIR, Inc. Model "Flight" mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The device can be easily folded for transport.
PERFORMANCE TESTING E.
The "Flight" mechanical wheelchair meets the applicable voluntary ANSI/RESNA standards for mechanical wheelchairs. The upholstery meets ANSI/RESNA WC Volume 1, Section 16: Determination of flammability.
1
LEGALLY MARKETED DEVICE FOR SUBSTANTIAL F. EQUIVALENCE COMPARISON
| 1. | Manufacturer: | Otto Bock, LP |
|---|---|---|
| 2. Model: | Start Basic | |
| 3. Cleared under: | K052681 | |
| 4. Date Cleared: | October 6, 2005 | |
| 5. Class: | Class I | |
| 6. Regulation Number | 890.3850 | |
| 7. Product Code(s): | IOR |
SUMMARY OF SUBSTANTIAL EQUIVALENCE G. COMPARISON
The new device and the predicate device have the same intended use. Both devices have the same weight bearing capacity and both devices are foldable for transportation or stowage. The overall dimensions are similar. The differences between the new device and the predicate are chiefly in the frame materials and in overall dimensions. These differences are not safety related, so the new device is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2006
Aero Innovative Research,Inc c/o Ms. Silvia Ankova Underwriters Laboratories, Inc. 333 Pfingsten Rd. Northbrook, Illinois 60062
Re: K061186
Trade/Device Name: Flight Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: April 24, 2006 Received: April 28, 2006
Dear Ms. Ankova:
We have reviewed your Section 510(k) premarket notification of intent to market the device w on re is 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 for associated in the 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. This letter will allow you to begin marketing your device as described in your Section 510(k)
3
Page 2- Mr. Mark W. Sheehan
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millhiser
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) No. If known
Indications For Use statement
Device Name:
Flight
Indications For Use:
Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.
| Prescription Use | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (Per 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| (510(k)) Number | K061186 |
|---|---|
| ----------------- | --------- |
Air, Inc.
Flight 510(k)
- |
March 6, 2006
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