Cleared Special

T-TECH DIGITAL, MODEL WL-22XXA SERIES (K033857) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033857 · Well-Life Healthcare, Inc. · Neurology device
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Dec 2003
Decision
8d
Days
Class 2
Risk

K033857 is an FDA 510(k) clearance for the T-TECH DIGITAL, MODEL WL-22XXA SERIES. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Well-Life Healthcare, Inc. (Taipei, TW). The FDA issued a Cleared decision on December 19, 2003 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Well-Life Healthcare, Inc. devices

Submission Details

510(k) Number K033857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2003
Decision Date December 19, 2003
Days to Decision 8 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d faster than avg
Panel avg: 148d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 605
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