Cleared Traditional

K871107 - VASOTRAIN 447

K871107 is an FDA 510(k) clearance for VASOTRAIN 447, manufactured by Henley Intl.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K871107 · Henley Intl. · Physical Medicine device
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May 1987
Decision
71d
Days
Class 1
Risk

K871107 is an FDA 510(k) clearance for the VASOTRAIN 447. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 - K871107

510(k) Number K871107 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 19, 1987
Decision Date May 29, 1987
Days to Decision 71 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
45d faster than avg
Panel avg: 116d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 64
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K871107.
LEG EEZE
K901931 · Jereva, Inc. · Jun 1990
CHIROPRACTIC MASSAGE PILLOW
K896947 · Intl. Pacific Industrial Corp. (Usa), Inc. · Jan 1990
LA MASSEUSE
K883913 · Sobel Shipping Co., Inc. · Nov 1988
SONAFON, THERAPEUTIC MASSAGER
K870972 · Electro Medica Office · Apr 1987
THUMPER (VIBRATOR/MASSAGER)
K860159 · Wellness Innovations Corp. · Feb 1986
AKUFON THERAPEUTIC MASSAGER
K850495 · Jansson A/S · Jan 1986
K871107 · VASOTRAIN 447
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