(76 days)
These products are intended to limit limb movement or finger movement in a hospital bed or gurney.
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 bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.
This document describes a 510(k) submission for protective restraints (limb holders) by T. T. Posey Co. It does not describe an AI/ML device or any study that would involve acceptance criteria, performance metrics, ground truth, or expert review in the context of AI/ML.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device (protective restraints) that has been on the market for a long time, not a submission for a new AI/ML-driven diagnostic or therapeutic device.
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T. T. Posey Co.
FI 133753
K96 3413
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Customer Service
Toll Free: (800) 44-POSEY
Tel: (818) 443-3143
Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY
NOV I 1 1996
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 13, 1996
Phone # (818) 443-3143 (818) 443-5014 FAX #
Reference Number : K963413
Trade Name: Protective Restraints Common Name: 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 bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.
These products are intended to limit limb movement or finger movement in a hospital bed or gurney.
The devices used for comparative purposes are identical to the limb holders as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is 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) Pre-market 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 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 years.
§ 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.