Cleared Traditional

K971536 - RESTRAINTS (VESTS AND JACKETS)

K971536 is an FDA 510(k) clearance for RESTRAINTS (VESTS AND JACKETS), 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 64-day FDA review.

K971536 · E.M. Adams Co., Inc. · General Hospital
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Jul 1997
Decision
64d
Days
Class 1
Risk

K971536 is an FDA 510(k) clearance for the RESTRAINTS (VESTS AND JACKETS). 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 July 1, 1997 after a review of 64 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 - K971536

510(k) Number K971536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date July 01, 1997
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 K971536.
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
PROVEST-PROTECTIVE RESTRAINT
K971561 · Jemm Medical Products · Jul 1997
PATIENT RESTRAINT
K970272 · Fla Orthopedics, Inc. · Apr 1997
PATIENT RESTRAINTS
K970273 · Fla Orthopedics, Inc. · Apr 1997
PATIENT RESTRAINTS
K970274 · Fla Orthopedics, Inc. · Apr 1997