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K Number
K971561
Device Name
PROVEST-PROTECTIVE RESTRAINT
Manufacturer
JEMM MEDICAL PRODUCTS
Date Cleared
1997-07-14

(76 days)

Product Code
FMQ
Regulation Number
880.6760
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.

Device Description

ProVest - Protective Restraint

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "ProVest - Protective Restraint" device. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the provided text DOES NOT contain any information regarding:

  • Acceptance criteria or reported device performance.
  • Any study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

The document primarily focuses on:

  • The FDA's decision of substantial equivalence.
  • Regulatory classifications and requirements.
  • Indications for Use for the ProVest device, which state: "ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support."

Therefore, I cannot provide the requested table and study details based on the input text. The document is a regulatory approval, not a performance study report.

§ 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.