Cleared Traditional

K912822 - PERSONAL BODY MASSAGER, MODELS 1605 & 1606

K912822 is an FDA 510(k) clearance for PERSONAL BODY MASSAGER, manufactured by Raymond Industrial, Ltd.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K912822 · Raymond Industrial, Ltd. · Physical Medicine device
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Feb 1992
Decision
231d
Days
Class 1
Risk

K912822 is an FDA 510(k) clearance for the PERSONAL BODY MASSAGER, MODELS 1605 & 1606. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Raymond Industrial, Ltd. (Norwalk, US). The FDA issued a Cleared decision on February 11, 1992 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Raymond Industrial, Ltd. devices

FDA 510(k) Submission Details - K912822

510(k) Number K912822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date February 11, 1992
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
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 27
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K912822.
INFRADERM
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VACOMED 4
K842802 · Robert Bosch Corp. · Aug 1984
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K833090 · Maddak, Inc. · Oct 1983