Cleared Traditional

K971948 - PATIENT RESTRAINT

K971948 is an FDA 510(k) clearance for PATIENT RESTRAINT, manufactured by E.M. Adams Co., Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K971948 · E.M. Adams Co., Inc. · General Hospital
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Aug 1997
Decision
70d
Days
Class 1
Risk

K971948 is an FDA 510(k) clearance for the PATIENT RESTRAINT. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by E.M. Adams Co., Inc. (Fort Pierce, US). The FDA issued a Cleared decision on August 6, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E.M. Adams Co., Inc. devices

FDA 510(k) Submission Details - K971948

510(k) Number K971948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1997
Decision Date August 06, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMQ Restraint, Protective

All 66
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K971948.
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · Skil-Care Corp. · May 2001
PEDO CUSH PEDO CUDDLE
K972446 · Cavity Free Kids, Inc. · Nov 1997
FULL BODY RESTRAINT SYSTEM
K972046 · Gillen Industries · Aug 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123 · Smith · Jul 1997
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · Depuy, Inc. · Jul 1997
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
K972338 · Geriatric Products, Inc. · Jul 1997