Cleared Traditional

K823927 - HIPUSH HANDHELD MASSAGER

K823927 is an FDA 510(k) clearance for HIPUSH HANDHELD MASSAGER, manufactured by New Age Corp.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K823927 · New Age Corp. · Physical Medicine device
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Feb 1983
Decision
48d
Days
Class 1
Risk

K823927 is an FDA 510(k) clearance for the HIPUSH HANDHELD MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by New Age Corp. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1983 after a review of 48 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.

FDA 510(k) Submission Details - K823927

510(k) Number K823927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1982
Decision Date February 15, 1983
Days to Decision 48 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
68d faster than avg
Panel avg: 116d · This submission: 48d
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 96
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K823927.
SENSORY ROLLER MASSAGER
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TRIMMORE ELECTION BEAUTIFIER
K821109 · Rn Int'L, Inc. · Aug 1982
SOFT & STROKE
K811782 · Phoenix Intl. Marketing, Inc. · Jul 1981
NORELCO MASSAGER PLUS HEAT BELT
K811891 · North American Philips Corp. · Jul 1981
K823927 · HIPUSH HANDHELD MASSAGER
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