Cleared Traditional

K990129 - TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR

K990129 is an FDA 510(k) clearance for TL250 INTERFERENTIAL/MUSCLE STIMULATOR ..., manufactured by Therapy Link, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K990129 · Therapy Link, Inc. · Neurology device
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Apr 1999
Decision
89d
Days
Class 2
Risk

K990129 is an FDA 510(k) clearance for the TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCL.... Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Therapy Link, Inc. (Lenexa, US). The FDA issued a Cleared decision on April 12, 1999 after a review of 89 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 Therapy Link, Inc. devices

FDA 510(k) Submission Details - K990129

510(k) Number K990129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1999
Decision Date April 12, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
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 42
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K990129.
DYNATRON STS RX
K010948 · Dynatronics Corp. · May 2001
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K993600 · Nisha Communication Industries · Feb 2001
SD-730 IF-SDS, PERFECT PULSE IF-SDS
K992652 · Skylark Device & Systems Co., Ltd. · Feb 2000
IF-727 INTERFERENTIAL STIMULATOR
K974585 · Skylark Device Co., Ltd. · Mar 1998
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
K952683 · Wholesale Medical Imports, Inc. · Apr 1997
DYNATRON 525
K961261 · Dynatronics Corp. · Sep 1996