Cleared Traditional

K163165 - AM-100 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163165 · BTL Industries, Inc. · Physical Medicine device
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Feb 2017
Decision
98d
Days
Class 2
Risk

K163165 is an FDA 510(k) clearance for the AM-100. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Framingham, US). The FDA issued a Cleared decision on February 16, 2017 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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

Submission Details

510(k) Number K163165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date February 16, 2017
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.
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 - NGX Stimulator, Muscle, Powered, For Muscle Conditioning

All 161
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