Cleared Traditional

K120093 - BTL ELITE

K120093 is an FDA 510(k) clearance for BTL ELITE, manufactured by BTL Industries, Inc.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K120093 · BTL Industries, Inc. · Physical Medicine device
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Oct 2012
Decision
267d
Days
Class 2
Risk

K120093 is an FDA 510(k) clearance for the BTL ELITE. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Waltham, US). The FDA issued a Cleared decision on October 5, 2012 after a review of 267 days - an extended review cycle.

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

View all BTL Industries, Inc. devices

FDA 510(k) Submission Details - K120093

510(k) Number K120093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2012
Decision Date October 05, 2012
Days to Decision 267 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
152d slower than avg
Panel avg: 115d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In 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 - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 25
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K120093.
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MEGAPULSE II
K973732 · Pti · Jan 1998