(8 days)
No
The device description details a purely mechanical, manually operated wheelchair with no mention of computational or learning capabilities.
No
The device is a manual wheelchair providing mobility and positioning for children, which is not considered a therapeutic function; its purpose is functional support rather than treatment or therapy.
No
The device is a manual wheelchair providing mobility. Its function does not involve diagnosing medical conditions or diseases.
No
The device is a manually operated, mechanical wheelchair with an aluminum frame and various physical components, clearly indicating it is a hardware device, not software-only.
Based on the provided information, 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 Invacare Model Solara Jr. Manual Wheelchair is a mechanical device designed to provide mobility and positioning support to children. It does not perform any tests on biological samples.
- Intended Use: The intended use is clearly stated as providing mobility to children limited to a sitting position. This is a physical support function, not a diagnostic one.
- Device Description: The description details the physical components and features of a wheelchair, such as the frame, wheels, seating, and tilt mechanism. There is no mention of any components or processes related to analyzing biological samples.
Therefore, the Invacare Model Solara Jr. Manual Wheelchair falls under the category of a medical device, specifically a mobility aid, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Solara Jr. Manual Wheelchair is to provide mobility to children limited to a sitting position.
Product codes
IOR
Device Description
The Invacare Corporation Model Solara Jr. is a manually operated, attendant propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to children who may need very specialized seating systems and tilt to assist in positioning and feeding.
The product consists of an aluminum frame, various options of rear wheel sizes, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. This device is a rigid, ason folding type of wheelchair that incorporates a solid seating surface. This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems currently available in the market. The upholstery, when provided by Invacare, meets the requirements of both the California Bureau of Home Furnishings 116 and 117 and the Boston Fire Department IX -1 Flammability Standards.
The Solara Jr. frame is constructed from aluminum tubing that is tig-welded. The frame is also secured with fasteners to allow the size of the chair to be adjusted as needed to accommodate the growth of the child. The homecare dealer can make many of the changes without additional parts.
The Solara Jr. also includes a "Tilt in Space" feature, which allows the seat and the back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature to help in positioning, comfort, or head control. It also serves as an attendant aid in those situations where the patient needs to be tilted, in order to be fed or attended to in some fashion. The Solara Jr. is primarily for attendant propelling. The attendant version of the chair is available with stroller type push handles for ease of attendant pushing and the optional stroller handles allows the attendant to push the chair while the occupant is tilted.
The "Tilt in Space" feature is manually operated and consists of two linear slides allowing the seat to tilt through a 50 degree range with little change in the overall center of gravity of the chair and the occupant. The tilting operation is initiated when the caregiver depresses the levers attached to the push handles. The levers in turn actuate cables that disengage a pair of latch mechanisms mounted to two of the frame rails. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The seat tilt range is from -5 degrees anterior through 45 degrees posterior.
The chair also has a recline only operation which changes the angle between the seat pan and the back of the chair. The chair is reclined by pulling up on the handles of the recliner cable assemblies to activate the gas cylinders and then slowly squeezing the handles of the recliner cables assemblies and allowing the back to recline at the desired angle. When the back is at the desired angle the handles are released.
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
children
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)
Performance Data specified in:
- Rehabilitation Engineering Society of North America (RESNA) Standard . ANSI/RESNA WC/Vol.1-1996 "Requirements and Test Methods for Wheelchairs (Including Scooters).
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
§ 890.3850 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
510(k) SUMMARY
Invacare Corporation's Model Solara Jr. Manual Wheelchair
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Rae Ann Farrow Contact Person: Manager, Regulatory Compliance
July 25, 2001 Date Prepared:
Name of Device and Name/Address of Sponsor
Model Solara Jr. Manual Wheelchair Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Manual Wheelchair Common or Usual Name:
Wheelchair, Mechanical 89IOR Classification Name:
Predicate Devices
The Invacare Solara Jr. is substantially equivalent to the Model "Action AT II" Manual Wheelchair (K984447, 1/8/99) and the "Action Wizard" Manual Wheelchair (K934646, 12/15/93).
Intended Use: The intended use of the Solara Jr. Manual Wheelchair is to provide mobility to children limited to a sitting position.
Technological Characteristics and Substantial Equivalence
Device Description The Invacare Corporation Model Solara Jr. is a manually operated, attendant propelled, manual, mechanical wheelchair. It's intended function and use is to
1
provide mobility to children who may need very specialized seating systems and tilt to assist in positioning and feeding.
The product consists of an aluminum frame, various options of rear wheel sizes, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. This device is a rigid, ason folding type of wheelchair that incorporates a solid seating surface. This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems currently available in the market. The upholstery, when provided by Invacare, meets the requirements of both the California Bureau of Home Furnishings 116 and 117 and the Boston Fire Department IX -1 Flammability Standards.
The Solara Jr. frame is constructed from aluminum tubing that is tig-welded. The frame is also secured with fasteners to allow the size of the chair to be adjusted as needed to accommodate the growth of the child. The homecare dealer can make many of the changes without additional parts.
The Solara Jr. also includes a "Tilt in Space" feature, which allows the seat and the back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature to help in positioning, comfort, or head control. It also serves as an attendant aid in those situations where the patient needs to be tilted, in order to be fed or attended to in some fashion. The Solara Jr. is primarily for attendant propelling. The attendant version of the chair is available with stroller type push handles for ease of attendant pushing and the optional stroller handles allows the attendant to push the chair while the occupant is tilted.
The "Tilt in Space" feature is manually operated and consists of two linear slides allowing the seat to tilt through a 50 degree range with little change in the overall center of gravity of the chair and the occupant. The tilting operation is initiated when the caregiver depresses the levers attached to the push handles. The levers in turn actuate cables that disengage a pair of latch mechanisms mounted to two of the frame rails. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The seat tilt range is from -5 degrees anterior through 45 degrees posterior.
The chair also has a recline only operation which changes the angle between the seat pan and the back of the chair. The chair is reclined by pulling up on the handles of the recliner cable assemblies to activate the gas cylinders and then slowly squeezing the handles of the recliner cables assemblies and allowing the back to recline at the desired angle. When the back is at the desired angle the handles are released.
Substantial Equivalence The Invacare Solara Jr. is substantially equivalent to the Model "Action AT II" Manual Wheelchair (K984447, 1/8/99) and the "Action Wizard" Manual Wheelchair (K934646, 12/15/93).
2
Performance Data
r errormance Data specified in:
- Rehabilitation Engineering Society of North America (RESNA) Standard . ANSI/RESNA WC/Vol.1-1996 "Requirements and Test Methods for Wheelchairs (Including Scooters).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle design with three parallel lines forming the body and head, and two curved lines representing the legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2001
Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44035
Re: K012370
Trade/Device Name: Invacare Model Solara Jr. Manual Wheelchair Regulation Number: 890.3850 Regulatory Class: I Product Code: IOR Dated: July 25, 2001 Received: July 26, 2001
Dear Ms. Farrow:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Rae Ann Farrow
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and in you substantial equivalence of your device to a legally marketed nouticate 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 and If you desire spoonne arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for millio areguestions on the promotion and advertising of your device, (2017 591 1059. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your responsionnate as the mumber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM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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
5
510(k) Number (if known): fBD KOIC 370
Device Name: Invacare Model Solara Jr. Manual Wheelchair
Indications For Use:
The intended use of the Invacare Model Solara Jr. Manual Wheelchair is to provide mobility to children limited to a sitting 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
OSMIHELLONO KNAUW
(Optional Format 1-2-96)
Over-The-Counter Use
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012370