Cleared Traditional

K940582 - MASSAGING HELMET C.F. HANSEN DESIGN

K940582 is an FDA 510(k) clearance for MASSAGING HELMET C.F. HANSEN DESIGN, manufactured by Philco Ushuaia. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K940582 · Philco Ushuaia · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
356d
Days
Class 1
Risk

K940582 is an FDA 510(k) clearance for the MASSAGING HELMET C.F. HANSEN DESIGN. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Philco Ushuaia (Canada, CA). The FDA issued a Cleared decision on January 30, 1995 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Philco Ushuaia devices

FDA 510(k) Submission Details - K940582

510(k) Number K940582 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 08, 1994
Decision Date January 30, 1995
Days to Decision 356 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
241d slower than avg
Panel avg: 115d · This submission: 356d
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 22
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K940582.
QI GONG MASSAGER
K955250 · East Health Development Group, Inc. · Feb 1996
CONAIR FAMILY FITNESS BODY ENERGY
K950441 · Conair Corp. · Jul 1995
CONAIR BODY AND SOLE
K950410 · Conair Corp. · May 1995
SQUEEZE PLAY
K943730 · Conair Corp. · Nov 1994
SONASSAGE
K923238 · Conair Corp. · Feb 1994
CARAPACE SUTURE REMOVAL TRAYS
K931819 · Carapace, Inc. · Jan 1994