(143 days)
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No
The document describes a physical restraint device and makes no mention of AI or ML technology.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a restraint for patient safety and comfort, not a therapeutic intervention.
No
The device is a protective restraint device used to limit patient movements in a wheelchair, not to diagnose a medical condition.
No
The device description clearly states it is a physical restraint device made of nylon or polyester webbing, indicating it is a hardware device, not software.
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 Description: The description clearly states the device is a "protective restraint device" intended to "limit patient movements" and "prevent the patient from sliding in a wheelchair." This is a physical restraint used externally on the patient.
- Intended Use: The intended use is to "limit patient movements thereby enabling examination or protection." This is a physical intervention, not a diagnostic test performed on a sample.
The device's function and intended use are entirely external to the body and do not involve analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Wheelchair Belt is indicated for use, at the discretion of a responsible licensed healtheare professional, to limit patient movements thereby enabling examination or protection of the DeRoyal Industries, Inc. Wheelchair Belt is intended to be used with a wheelchair only.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Wheelchair Belt is a protective restraint device that is intended for medical purposes to limit patient movements thereby helping prevent the patient from sliding in a wheelchair.
Device Design/Materials Used/Physical Properties: The DeRoyal Wheelchair Belt is designed similar to those marketed by other manufacturers. The Wheelchair Belt is primarily comprised of nylon or polyester seat belt webbing,
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
responsible licensed healtheare professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.3910 Wheelchair accessory.
(a)
Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.(b)
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
0
JAN 2 4 1997
DeRoyal Industries, Inc. Wheelchair Belt
K9663479
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoval Industries, Inc. ADDRESS: 200 DeBusk Lane Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 938-7828 Camille Matlock August 30, 1996
DEVICE NAMES
NAME: DeRoyal Industries, Inc. Wheelchair Belt COMMON/USUAL NAME: Wheelchair Belt Restraint, Protective (80FMQ) CLASSIFICATION NAME (if known):
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Wheelchair Belt is a protective restraint device that is intended for medical purposes to limit patient movements thereby helping prevent the patient from sliding in a wheelchair.
Device Design/Materials Used/Physical Properties: The DeRoyal Wheelchair Belt is designed similar to those marketed by other manufacturers. The Wheelchair Belt is primarily comprised of nylon or polyester seat belt webbing,
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Wheelchair Belt is indicated for use, at the discretion of a responsible licensed healtheare professional, to limit patient movements thereby enabling examination or protection of the DeRoyal Industries, Inc. Wheelchair Belt is intended to be used with a wheelchair only.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of nylon or polyester seat | |
| belt webbing. Materials also include blue purr | ||
| and foam rubber for soft padding. Fasteners | ||
| are either a hook and loop or a buckle. | Same | |
| Size | Universal | Same |
| Vehicles for | ||
| Attachment | Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient | ||
| Activity | For patients that tend to slide in their chairs | Same |