Cleared Traditional

K091248 - MAXEMS, MODELS 1000 AND 2000

K091248 is an FDA 510(k) clearance for MAXEMS, manufactured by Bio Protech, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K091248 · Bio Protech, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
216d
Days
Class 2
Risk

K091248 is an FDA 510(k) clearance for the MAXEMS, MODELS 1000 AND 2000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on November 30, 2009 after a review of 216 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 Bio Protech, Inc. devices

FDA 510(k) Submission Details - K091248

510(k) Number K091248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2009
Decision Date November 30, 2009
Days to Decision 216 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
101d slower than avg
Panel avg: 115d · This submission: 216d
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 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K091248.
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003
K093138 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2010
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
K100117 · Shenzhen Dongdixin Technology Co., Ltd. · Jan 2010
KNEEHAB XP CONTROLLER, MODEL 411
K092791 · Bio-Medical Research, Ltd. · Dec 2009
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
K083105 · Bio-Medical Research, Ltd. · Jul 2009
VECTRA GENISYS VMS FR
K062354 · Encore Medical, L.P. · Jan 2007
MYOTRAC INFINITI
K053266 · Thought Technology , Ltd. · Dec 2005