Cleared Traditional

K952441 - LEGEND

K952441 is an FDA 510(k) clearance for LEGEND, manufactured by Health Care Mfg., Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K952441 · Health Care Mfg., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
25d
Days
Class 1
Risk

K952441 is an FDA 510(k) clearance for the LEGEND. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Health Care Mfg., Inc. (Springfield, US). The FDA issued a Cleared decision on June 19, 1995 after a review of 25 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 Health Care Mfg., Inc. devices

FDA 510(k) Submission Details - K952441

510(k) Number K952441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date June 19, 1995
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 116d · This submission: 25d
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 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K952441.
THE HILL ADJUSTABLE COUNTERSTRAIN TABLE
K952356 · Hill Laboratories Co. · Jun 1995
THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE
K952358 · Hill Laboratories Co. · Jun 1995
THE HILL ADJUSTABLE HA90C
K952359 · Hill Laboratories Co. · Jun 1995
CARDON PHYSICAL THERAPY TABLES MODELS R28591 & R28592
K951906 · Cardon Rehabilitation Products, Inc. · Jun 1995
CARDON PHYSICAL THERAPY TABLE MODEL R27112
K951952 · Cardon Rehabilitation Products, Inc. · May 1995
CARDON PHSICAL THERAPY TABLE MODEL R27630
K951953 · Cardon Rehabilitation Products, Inc. · May 1995