Cleared Traditional

K963528 - ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)

K963528 is an FDA 510(k) clearance for ALIMED POSITIONING 7 SAFETY STRAPS (THR..., manufactured by Alimed, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K963528 · Alimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
55d
Days
Class 1
Risk

K963528 is an FDA 510(k) clearance for the ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY .... Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Alimed, Inc. (Dedham, US). The FDA issued a Cleared decision on October 29, 1996 after a review of 55 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 Alimed, Inc. devices

FDA 510(k) Submission Details - K963528

510(k) Number K963528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1996
Decision Date October 29, 1996
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
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 121
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963528.
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS
K963527 · Alimed, Inc. · Oct 1996
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER
K963378 · Medline Industries, Inc. · Oct 1996
MEDLINE OPEN END FINGER CONTROL MITT
K963504 · Medline · Oct 1996
STRAP WEDGE
K963526 · Alimed, Inc. · Oct 1996
CHECKMATE ANKLE RESTRAINT SYSTEM
K962963 · Hollister, Inc. · Oct 1996
HEELBO JOHNNY GRAIT BELT SECURITY BELT
K962964 · Hollister, Inc. · Oct 1996