Cleared Traditional

K081255 - SCRAMBLER ST 5 TENS DEVICE

K081255 is an FDA 510(k) clearance for SCRAMBLER ST 5 TENS DEVICE, manufactured by Competitive Technologies,Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K081255 · Competitive Technologies,Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
294d
Days
Class 2
Risk

K081255 is an FDA 510(k) clearance for the SCRAMBLER ST 5 TENS DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Competitive Technologies,Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 294 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Competitive Technologies,Inc. devices

FDA 510(k) Submission Details - K081255

510(k) Number K081255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2008
Decision Date February 20, 2009
Days to Decision 294 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 148d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 189
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K081255.
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · Empi · Jun 2009
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
K082190 · Bio-Medical Research, Ltd. · Mar 2009
DX6605E-TENS, DX6605E-G, DX6609-G
K082057 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2009
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · Bio-Medical Research, Ltd. · Nov 2008
PRO TENS, MODEL WL-240 RX
K080304 · Well-Life Healthcare Limited · Jun 2008
PROSTIM 1000/2000
K073438 · Bio Protech, Inc. · Feb 2008