Cleared Traditional

K182682 - OrthoGold 100

K182682 is the FDA 510(k) clearance for OrthoGold 100 by Tissue Regeneration Technologies. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K182682 · Tissue Regeneration Technologies · Physical Medicine device
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Dec 2018
Decision
86d
Days
Class 1
Risk

K182682 is an FDA 510(k) clearance for the OrthoGold 100. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Tissue Regeneration Technologies (Woodstock, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 86 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.

View all Tissue Regeneration Technologies devices

Submission Details

510(k) Number K182682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2018
Decision Date December 21, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 Consultant

Msquared Associates, Inc.
Jennifer A. Daudelin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 14
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K182682.
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