Cleared Traditional

K963561 - ULTRA CARE VEST STYLE BODY HOLDER

K963561 is an FDA 510(k) clearance for ULTRA CARE VEST STYLE BODY HOLDER, manufactured by Tecnol Medical Products, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K963561 · Tecnol Medical Products, Inc. · General Hospital
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Nov 1996
Decision
77d
Days
Class 1
Risk

K963561 is an FDA 510(k) clearance for the ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020.... Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Tecnol Medical Products, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 77 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 Tecnol Medical Products, Inc. devices

FDA 510(k) Submission Details - K963561

510(k) Number K963561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date November 21, 1996
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 42
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963561.
24448-010 SECURE-ALL FINGER CONTROL MITT
K963554 · Tecnol Medical Products, Inc. · Nov 1996
SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
K963556 · Tecnol Medical Products, Inc. · Nov 1996
SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
K963557 · Tecnol Medical Products, Inc. · Nov 1996
ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
K963563 · Tecnol Medical Products, Inc. · Nov 1996
24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
K963773 · Tecnol Medical Products, Inc. · Nov 1996
MITTENS
K963469 · Deroyal Industries, Inc. · Nov 1996