(72 days)
Not Found
Not Found
No
The device description and intended use are for a physical restraint, and there is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a restraint used to limit movement for examination or protection, and does not provide therapy.
No
The device is described as a restraint to limit movement for safety or examination, not to diagnose a condition.
No
The device description clearly states it is a physical vest restraint made of materials like cool knit, cotton, or polyester with nylon or steel fasteners. This indicates 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 clearly states the device is used to "limit movements thereby enabling examination or protection of the patient or others." This is a physical restraint used on a patient.
- Device Description: The description reinforces that it's a physical device made of fabric and fasteners, designed to limit movement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, the DeRoyal Industries, Inc. Sleeveless Vest Restraint is a physical medical device, not an IVD.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Sleeveless Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoval Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeved/ Sleeved/ Sleeved/ of cool knit, cotton, or with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
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
responsible 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
NOV 1 1 1996
DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint
510(k) Summarv
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
FI LEPHONE: 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. Sleeved/ Sleeveless Vest Restraint Sleeved/ Sleeveless Vest Restraint Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posev Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoval Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeved/ Sleeved/ Sleeved/ of cool knit, cotton, or with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Sleeveless Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to 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 tietex, cotton flannel or polyester cool | |
| knit. The straps are made of polyester twill tape and white | ||
| webbing. Fasteners are made of hook and loop or steel nickel | ||
| plated buckles. | Same | |
| Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX- | |
| Large | Same | |
| Vehicles for Attachment | Bed or Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Mildly to moderately agitated or disoriented | Same |