Who is the manufacturer of PATIENT RESTRAINTS?

Fla Orthopedics, Inc. submitted the Traditional clearance for PATIENT RESTRAINTS (K970274).

What is the FDA product code for PATIENT RESTRAINTS?

FMQ. It is classified under 21 CFR 880.6760 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for PATIENT RESTRAINTS?

510(k) clearance (submission type: Traditional).

PATIENT RESTRAINTS

K970274 · Fla Orthopedics, Inc. · FMQ · Apr 11, 1997 · General Hospital

Device Facts

Record ID	K970274
Device Name	PATIENT RESTRAINTS
Applicant	Fla Orthopedics, Inc.
Product Code	FMQ · General Hospital
Decision Date	Apr 11, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1

Regulatory Classification

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.