(72 days)
None
Not Found
No
The summary describes a physical restraint device with no mention of software, data processing, or AI/ML terms.
No.
The device acts as a protective restraint to limit limb movements for examination or protection, rather than directly treating a medical condition.
No
Explanation: The device is a limb holder, described as a "protective restraint device" intended to "limit patient limb movements" to enable examination or protection. It does not analyze or interpret bodily data to provide a diagnosis.
No
The device description clearly states it is comprised of physical materials like flannel, webbing, and buckles, indicating it is a physical restraint device, not software.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The DeRoyal Industries, Inc. Reusable Limb Holder is a physical restraint device used to limit patient limb movement. It does not involve testing samples from the body or providing diagnostic information.
- Intended Use: The intended use is to "limit limb movements thereby enabling examination of the patient or others." This is a physical intervention, not a diagnostic test.
Therefore, based on the provided information, the DeRoyal Industries, Inc. Reusable Limb Holder is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Reusable Limb Holder is indicated for use, at the discretion of a responsible licensed healthicare professional, to limit limb movements thereby enabling examination of the patient or others. The Reusable Limb Holder can be used with a gurney, bed, or stretcher.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Reusable Limb Holder is a protective restraint device that is intended for medical purposes to limit patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Reusable Limb Holder is designed similar to those marketed by other manufacturers. The Reusable Limb Holder is primarily comprised of a flannel and/or blue purr material. The straps are made of white webbing. The fasteners include a nylon hook and 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 healthicare 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
Not Found
Key Metrics
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 14 1996
K963473
DeRoyal Industries, Inc. Reusable Limb 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
THEPHONE: 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. Reusable Limb Holder Reusable Limb Holder Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Reusable Limb Holder is a protective restraint device that is intended for medical purposes to limit patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Reusable Limb Holder is designed similar to those marketed by other manufacturers. The Reusable Limb Holder is primarily comprised of a flannel and/or blue purr material. The straps are made of white webbing. The fasteners include a nylon hook and steel nickel plated buckles.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Reusable Limb Holder is indicated for use, at the discretion of a responsible licensed healthicare professional, to limit limb movements thereby enabling examination of the patient or others. The Reusable Limb Holder can be used with a gurney, bed, or stretcher.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of flannel and/or blue purr | |
| material. The straps are made of white | ||
| webbing. Fasteners include nylon hook and | ||
| steel nickel plated buckles. | Same | |
| Size | Universal | Same |
| Vehicles for | ||
| Attachment | Gurney, Bed, or Stretcher | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient | ||
| Activity | Mildly to moderately agitated or disoriented | Same |