Cleared Traditional

K921000 - SONACARE SOUND MASSAGER

K921000 is an FDA 510(k) clearance for SONACARE SOUND MASSAGER, manufactured by Honor Trading, Ltd.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K921000 · Honor Trading, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
398d
Days
Class 1
Risk

K921000 is an FDA 510(k) clearance for the SONACARE SOUND MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Honor Trading, Ltd. (Fremont, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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: 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 Honor Trading, Ltd. devices

FDA 510(k) Submission Details - K921000

510(k) Number K921000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date March 31, 1993
Days to Decision 398 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 115d · This submission: 398d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

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 28
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K921000.
INFRADERM
K911727 · Conair Corp. · Feb 1994
BODY SOOTHER
K924518 · Conair Corp. · Oct 1993
BODY TRAINER
K924520 · Conair Corp. · Sep 1993
VIBRATOUCH II CORDLESS WAND MASSAGER
K912383 · Conair Corp. · Oct 1991
VACOMED 4
K842802 · Robert Bosch Corp. · Aug 1984
SENSORY ROLLER MASSAGER
K833090 · Maddak, Inc. · Oct 1983