Cleared Traditional

K070541 - IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II

K070541 is an FDA 510(k) clearance for IVIVI SOFPULSE, manufactured by Ivivi Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 654-day FDA review.

K070541 · Ivivi Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
654d
Days
Class 2
Risk

K070541 is an FDA 510(k) clearance for the IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Ivivi Technologies, Inc. (Northvale, US). The FDA issued a Cleared decision on December 11, 2008 after a review of 654 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K070541

510(k) Number K070541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date December 11, 2008
Days to Decision 654 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
538d slower than avg
Panel avg: 116d · This submission: 654d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

All 13
Devices cleared under the same product code (ILX) and FDA review panel - the closest regulatory comparables to K070541.
PROVANT SYSTEM, MODEL 4201
K091791 · Regenesis Biomedical, Inc. · Apr 2010
ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
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ORTHOCOR KNEE SYSTEM BASIC
K091996 · Orthocor Medical · Dec 2009
MODEL PMT850
K070931 · Promedtek, Inc. · May 2007
ACTIBAND
K022404 · Paw, LLC · Aug 2002
REGENESIS MODEL 42
K972093 · Regenesis Biomedical, Inc. · Oct 1997
K070541 · IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
Download PDF FDA Summary Ivivi Technologies, I…