Cleared Traditional

K863197 - VIBROFLEX

K863197 is the FDA 510(k) clearance for VIBROFLEX by Stoffregen & Co., Inc.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K863197 · Stoffregen & Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
31d
Days
Class 1
Risk

K863197 is an FDA 510(k) clearance for the VIBROFLEX. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Stoffregen & Co., Inc. (Anaheim, US). The FDA issued a Cleared decision on September 19, 1986 after a review of 31 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.

View all Stoffregen & Co., Inc. devices

Submission Details

510(k) Number K863197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1986
Decision Date September 19, 1986
Days to Decision 31 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
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 - ISA Massager, Therapeutic, Electric

All 15
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K863197.
OMRON MASSAGER MODEL HM-45
K935459 · Omron Healthcare, Inc. · Mar 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
K935462 · Omron Healthcare, Inc. · Mar 1994
OMRON MASSAGER MODEL HM-102
K935581 · Omron Healthcare, Inc. · Mar 1994
SENSORY ROLLER MASSAGER
K833090 · Maddak, Inc. · Oct 1983
MAGIC CUSHION MASSAGER
K810447 · Fred Sammons, Inc. · Mar 1981