Cleared Traditional

K792064 - DELTA ROLLING SELF-LICKING WALKER

K792064 is an FDA 510(k) clearance for DELTA ROLLING SELF-LICKING WALKER, manufactured by Staricat, Inc.. The device is a Class 1 Physical Medicine device with product code ITJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K792064 · Staricat, Inc. · Physical Medicine device
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Oct 1979
Decision
15d
Days
Class 1
Risk

K792064 is an FDA 510(k) clearance for the DELTA ROLLING SELF-LICKING WALKER. Classified as Walker, Mechanical (product code ITJ), Class I - General Controls.

Submitted by Staricat, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1979 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3825 - 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.

FDA 510(k) Submission Details - K792064

510(k) Number K792064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1979
Decision Date October 30, 1979
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

ITJ Device Classification - Class 1, General Controls

Product Code ITJ Walker, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3825
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 - ITJ Walker, Mechanical

All 13
Devices cleared under the same product code (ITJ) and FDA review panel - the closest regulatory comparables to K792064.
LIGHT WEIGHT ALUMINUM WALKER
K821404 · Manuco Manufacturing Co., Inc. · May 1982
WALK-A-CYCLE
K820711 · Walk-A-Cycle Division · Apr 1982
WALKER/CRUTCH BAG
K811485 · Fred Sammons, Inc. · Jun 1981
WALKING AID
K790529 · Maddak, Inc. · Apr 1979
WALKING AID
K772049 · Guardian Products Co., Inc. · Nov 1977
ANIMATOR
K770417 · Kdk Medical Products · Apr 1977
K792064 · DELTA ROLLING SELF-LICKING WALKER
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