Cleared Traditional

K131222 - AMPCARE ESP THERAPY SYSTEM

K131222 is an FDA 510(k) clearance for AMPCARE ESP THERAPY SYSTEM, manufactured by Ampcare, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K131222 · Ampcare, LLC · Physical Medicine device
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Oct 2013
Decision
184d
Days
Class 2
Risk

K131222 is an FDA 510(k) clearance for the AMPCARE ESP THERAPY SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ampcare, LLC (Richardson, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 184 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K131222

510(k) Number K131222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date October 31, 2013
Days to Decision 184 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 116d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 370
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K131222.
TONE-A-MATIC
K130052 · Tone-A-Matic International, Inc. · Dec 2013
ELECTROTHERAPY DEVICE (COMBO UNIT)
K130691 · Guangzhou Finecure Medical Equipment Co.,Ltd · Dec 2013
NEURODYN MULTIWAVE, AUSSIE SPORT
K131629 · Ibramed Equipamentos Medicos · Nov 2013
MULTISTIM
K132137 · Metron Medical Australia, Pty, Ltd. · Sep 2013
STIMEL-03
K130424 · Stimel, Ltd. · Jul 2013
REVITIVE IX
K123354 · Actegy , Ltd. · Jun 2013