Cleared Traditional

K073008 - KFH ENERGY, MODEL: E1

K073008 is an FDA 510(k) clearance for KFH ENERGY, manufactured by Kingfisher Healthcare NV. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K073008 · Kingfisher Healthcare NV · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2008
Decision
139d
Days
Class 2
Risk

K073008 is an FDA 510(k) clearance for the KFH ENERGY, MODEL: E1. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Kingfisher Healthcare NV (Stevenage, GB). The FDA issued a Cleared decision on March 11, 2008 after a review of 139 days - within the typical 510(k) review window.

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 Kingfisher Healthcare NV devices

FDA 510(k) Submission Details - K073008

510(k) Number K073008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2007
Decision Date March 11, 2008
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 149d · This submission: 139d
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 346
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K073008.
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PROSTIM 1000/2000
K073438 · Bio Protech, Inc. · Feb 2008
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