Cleared Traditional

K950361 - CARDON PHYSICAL THERAPY TABLE R28575

K950361 is an FDA 510(k) clearance for CARDON PHYSICAL THERAPY TABLE R28575, manufactured by Cardon Rehabilitation Products, Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K950361 · Cardon Rehabilitation Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
11d
Days
Class 1
Risk

K950361 is an FDA 510(k) clearance for the CARDON PHYSICAL THERAPY TABLE R28575. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Cardon Rehabilitation Products, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - the FDA physical medicine 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 Cardon Rehabilitation Products, Inc. devices

FDA 510(k) Submission Details - K950361

510(k) Number K950361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1995
Decision Date February 10, 1995
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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 - INQ Table, Powered

All 48
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K950361.
THE HILL HI-LO TABLE
K934754 · Hill Laboratories Co. · Feb 1995
THE HILL ADJUSTABLE HA90E
K942026 · Hill Laboratories Co. · Feb 1995
CARDON PHYSICAL THERAPY TABLE MODEL R28535
K950360 · Cardon Rehabilitation Products, Inc. · Feb 1995
CARDON PHYSICAL THERAPY TABLE R27114 AND R27642
K950362 · Cardon Rehabilitation Products, Inc. · Feb 1995
CARDONPHYSICAL THERAPY TABLE R27110
K950363 · Cardon Rehabilitation Products, Inc. · Feb 1995
CARDON PHYSICAL THERAPY TABLES R27635
K950364 · Cardon Rehabilitation Products, Inc. · Feb 1995