Cleared Traditional

K041359 - BODY CLOCK STIMPLUS AND STIMPLUS PRO

K041359 is an FDA 510(k) clearance for BODY CLOCK STIMPLUS AND STIMPLUS PRO, manufactured by Body Clock Health Care, Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K041359 · Body Clock Health Care, Ltd. · Neurology device
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Aug 2004
Decision
91d
Days
Class 2
Risk

K041359 is an FDA 510(k) clearance for the BODY CLOCK STIMPLUS AND STIMPLUS PRO. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Body Clock Health Care, Ltd. (London, GB). The FDA issued a Cleared decision on August 20, 2004 after a review of 91 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 Body Clock Health Care, Ltd. devices

FDA 510(k) Submission Details - K041359

510(k) Number K041359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2004
Decision Date August 20, 2004
Days to Decision 91 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
58d faster than avg
Panel avg: 149d · This submission: 91d
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 344
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