Cleared Traditional

K052289 - DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE

K052289 is an FDA 510(k) clearance for DEEPWAVE NEUROMODULATION PAIN THERAPY D..., manufactured by Biowave Corporation. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K052289 · Biowave Corporation · Neurology device
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Dec 2005
Decision
112d
Days
Class 2
Risk

K052289 is an FDA 510(k) clearance for the DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Biowave Corporation (North Attleboro, US). The FDA issued a Cleared decision on December 13, 2005 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biowave Corporation devices

FDA 510(k) Submission Details - K052289

510(k) Number K052289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2005
Decision Date December 13, 2005
Days to Decision 112 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
37d faster than avg
Panel avg: 149d · This submission: 112d
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 48
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K052289.
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K090023 · Well-Life Healthcare Limited · Jan 2009
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K070890 · Everlife Medical Equipment Co., Ltd. · Jun 2007
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
K060975 · Theratech, Inc. · May 2006
INF 4160, MODEL D-FJ27F
K043407 · Fuji Dynamics Limited · Feb 2005
INFINITY ELECTROTHERAPY SYSTEM
K042057 · Empi · Dec 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc. · Jul 2004