Cleared Traditional

K915361 - THE BODY BUGGY

K915361 is an FDA 510(k) clearance for THE BODY BUGGY, manufactured by Innova Corp.. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K915361 · Innova Corp. · Physical Medicine device
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Dec 1991
Decision
23d
Days
Class 1
Risk

K915361 is an FDA 510(k) clearance for the THE BODY BUGGY. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Innova Corp. (Montclair, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 - K915361

510(k) Number K915361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date December 20, 1991
Days to Decision 23 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 116d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

LYG Device Classification - Class 1, General Controls

Product Code LYG Massager, Therapeutic, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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 - LYG Massager, Therapeutic, Manual

All 11
Devices cleared under the same product code (LYG) and FDA review panel - the closest regulatory comparables to K915361.
STRESS HANDLER
K936148 · Arocep Enterprises , Ltd. · Apr 1994
THE MASSAGER
K924315 · Four Directions · Oct 1993
SPINE LINE
K922366 · Dambrecine, Inc. · Jul 1992
TAICHI STICK MASSAGER
K912512 · Focus International, Inc. · Sep 1991
THERA-CANE
K903820 · Pro Message Co. · Sep 1990
DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER
K881080 · Ferguson Medical · Jul 1988
K915361 · THE BODY BUGGY
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