Cleared Traditional

K130691 - ELECTROTHERAPY DEVICE (COMBO UNIT)

K130691 is an FDA 510(k) clearance for ELECTROTHERAPY DEVICE (COMBO UNIT), manufactured by Guangzhou Finecure Medical Equipment Co.,Ltd. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K130691 · Guangzhou Finecure Medical Equipment Co.,Ltd · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
282d
Days
Class 2
Risk

K130691 is an FDA 510(k) clearance for the ELECTROTHERAPY DEVICE (COMBO UNIT). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Guangzhou Finecure Medical Equipment Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on December 20, 2013 after a review of 282 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.

View all Guangzhou Finecure Medical Equipment Co.,Ltd devices

FDA 510(k) Submission Details - K130691

510(k) Number K130691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2013
Decision Date December 20, 2013
Days to Decision 282 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 115d · This submission: 282d
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 157
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K130691.
geko T-2 and geko Plus R-2
K180082 · Firstkind, Ltd. · Feb 2018
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Oct 2017
HPM-6000
K160992 · BTL Industries, Inc. · Oct 2016
SYS*STIM 240
K113017 · Mettler Electronics Corp. · Jun 2012
EMPI CONTINUUM
K093324 · Empi · Mar 2010
KNEEHAB XP CONTROLLER, MODEL 411
K092791 · Bio-Medical Research, Ltd. · Dec 2009