Cleared Traditional

K924581 - HEALTH ESSENTIALS MAXI MASSAGER

K924581 is an FDA 510(k) clearance for HEALTH ESSENTIALS MAXI MASSAGER, manufactured by Conair Corp.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 397-day FDA review.

K924581 · Conair Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
397d
Days
Class 1
Risk

K924581 is an FDA 510(k) clearance for the HEALTH ESSENTIALS MAXI MASSAGER. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 397 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 Conair Corp. devices

FDA 510(k) Submission Details - K924581

510(k) Number K924581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1992
Decision Date October 12, 1993
Days to Decision 397 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
282d slower than avg
Panel avg: 115d · This submission: 397d
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 21
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K924581.
CARAPACE SUTURE REMOVAL TRAYS
K931819 · Carapace, Inc. · Jan 1994
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431 · Conair Corp. · Oct 1993
BODYTHERM
K924519 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS BODY CARE MASSAGER
K924582 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K924583 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K924584 · Conair Corp. · Oct 1993