(81 days)
Not Found
None
No
The summary describes a physical restraint device with no mention of software, data processing, or AI/ML terms.
No
The device is described as limiting limb or finger movement for restraint purposes in a hospital bed or crib, which is not a therapeutic function.
No
The device description states its purpose is to "limit limb movement or finger movement," and it is secured to a hospital bed or crib. This indicates a physical restraint function, not a diagnostic one (identifying a disease or condition).
No
The device description clearly describes physical restraints (straps, knots, safety pins) used to limit movement, 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:
- Intended Use: The intended use is to "limit limb movement or finger movement in a hospital bed or crib." This is a physical restraint device used for patient management, not for diagnosing a condition.
- Device Description: The description details a physical device that encircles limbs and is secured to a bed. This aligns with a physical restraint, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
These products are intended to limit limb movement or finger movement in a hospital bed or crib.
Product codes
Not Found
Device Description
The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs (wrists, hands, ankles)
Indicated Patient Age Range
Pediatric
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)
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
Image /page/0/Picture/1 description: The image is a black and white drawing of a four-leaf clover inside of a circle. The word "Quality" is written in cursive below the clover. The clover is solid black, and the circle is a thin black line. The drawing is simple and clean.
J. T. Posey Co.
Posey Company
5635 Peck Road · Arcadla, California 91006-0020 U.S.A.
818 443 5064 P.10/11
×963439
Customer Service Toll Free: (800) 44-POSEY Tel: (818) 443-3143 Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY NOV 1 9 1996
JT Posey Company 5835 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18, 1996
Phone # (818) 443-3143 (818) 443-5014 FAX #
Reference Number: K963439
Trade Name: Protective Restraints Common Name: Pedjatric limb holders Classification Name: Protective Restraints
The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin.
These products are intended to limit limb movement or finger movement in a hospital bed or crib.
The devices used for comparative purposes are identical to the pediatric limb holders as described in this submission and produced or sold by the J.T. Posey Co. This premarket submitted in response to the agency's final rule published on March 4, 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison:
"Predicate device
FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products."
The pediatric limb holders are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission. August 30,1996. The limb holders have been manufactured and in commercial distribution for up to 20 vears.