Cleared Traditional

K881080 - DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER

K881080 is an FDA 510(k) clearance for DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER, manufactured by Ferguson Medical. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K881080 · Ferguson Medical · Physical Medicine device
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Jul 1988
Decision
129d
Days
Class 1
Risk

K881080 is an FDA 510(k) clearance for the DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 129 days - within the typical 510(k) review window.

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 Ferguson Medical devices

FDA 510(k) Submission Details - K881080

510(k) Number K881080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1988
Decision Date July 21, 1988
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

LYG Device Classification - Class 1, General Controls

Product Code LYG Massager, Therapeutic, Manual
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.