(141 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical restraint device made of nylon or cotton, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is described as a "protective restraint device" used to limit patient movements for examination or protection, not for treating a disease or condition.
No
This device is a physical restraint, not a device used to diagnose a medical condition. Its purpose is to limit patient movement for examination or protection, as stated in the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description clearly states it is a physical restraint device made of nylon or cotton, 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:
- Intended Use: The intended use is to "limit patient movements thereby enabling examination or protection of the patient or others." This describes a physical restraint used on a patient's body.
- Device Description: The description confirms it's a "protective restraint device" made of materials like nylon or cotton.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment based on sample analysis.
- Any laboratory or analytical procedures.
IVD devices are used to perform tests on samples taken from the body, not to physically interact with the body itself in the way a restraint does.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enamination or protection of th patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Bod Holder is a protective restraint which can be used with a bed or wheelchair.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intend medical purposes to limit patients thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Multi-Purpose Utility Restraint/ Body Holde designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint Body Holder is prima - comprised of nylon or cotton.
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
licensed healthcare professional
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
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 2 1997
Y96934880
DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoyal 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: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder Utility Restraint/ Body Holder Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intend medical purposes to limit patients thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Multi-Purpose Utility Restraint/ Body Holde designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint Body Holder is prima - comprised of nylon or cotton.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enamination or protection of th patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Bod Holder is a protective restraint which can be used with a bed or wheelchair.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of nylon or cotton. | |
| Materials also include blue purr foam, white | ||
| binding, and webbing. | Same | |
| Size | Universal | Same |
| Vehicles for | ||
| Attachment | Body Holder: Bed or Wheelchair | |
| Multi-Purpose Utility Restraint: OR Table, | ||
| Gurney, Bed, or Stretcher | Same | |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient | ||
| Activity | Mildly Agitated or Disoriented | |
| Surgical Patient | ||
| Patient Transport | Same |