Cleared Traditional

K895334 - TTS2600

K895334 is an FDA 510(k) clearance for TTS2600, manufactured by Henley Intl.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K895334 · Henley Intl. · Neurology device
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Oct 1989
Decision
61d
Days
Class 2
Risk

K895334 is an FDA 510(k) clearance for the TTS2600. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Henley Intl. devices

FDA 510(k) Submission Details - K895334

510(k) Number K895334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date October 30, 1989
Days to Decision 61 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 148d · This submission: 61d
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 264
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K895334.
TTS2800
K895161 · Henley Intl. · Oct 1989
TTS2500
K895166 · Henley Intl. · Oct 1989
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K895211 · Henley Intl. · Oct 1989
TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K884972 · Futuremed Div. of Future Impex Corp. · Jul 1989
MODIFIED MRL NEUROPROBE SYSTEM V
K884869 · Medical Research Laboratories, Inc. · Jun 1989