Cleared Traditional

K010948 - DYNATRON STS RX

K010948 is an FDA 510(k) clearance for DYNATRON STS RX, manufactured by Dynatronics Corp.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K010948 · Dynatronics Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
47d
Days
Class 2
Risk

K010948 is an FDA 510(k) clearance for the DYNATRON STS RX. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on May 15, 2001 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Dynatronics Corp. devices

FDA 510(k) Submission Details - K010948

510(k) Number K010948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2001
Decision Date May 15, 2001
Days to Decision 47 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 148d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - LIH Interferential Current Therapy

All 34
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K010948.
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc. · Jul 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
DYNATRON STS
K010565 · Dynatronics Corp. · May 2001
IF-727 INTERFERENTIAL STIMULATOR
K974585 · Skylark Device Co., Ltd. · Mar 1998
DYNATRON 525
K961261 · Dynatronics Corp. · Sep 1996
ISOTRON III, ISOTRON IV
K955387 · Excel Tech. , Ltd. · Mar 1996