Cleared Traditional

K800117 - TRU-PULSE PADS

K800117 is an FDA 510(k) clearance for TRU-PULSE PADS, manufactured by Ipco Corp.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K800117 · Ipco Corp. · Neurology device
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Feb 1980
Decision
24d
Days
Class 2
Risk

K800117 is an FDA 510(k) clearance for the TRU-PULSE PADS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ipco Corp. (Mchenry, US). The FDA issued a Cleared decision on February 11, 1980 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

FDA 510(k) Submission Details - K800117

510(k) Number K800117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 11, 1980
Days to Decision 24 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
125d faster than avg
Panel avg: 149d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 440
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K800117.
DUAL TYPE ELECTRODE
K810206 · Professional Instruments Co. · Mar 1981
AUTOMATIC ELECTRODE PLACEMENT BELT
K810262 · Wallant Intl. Trade, Inc. · Mar 1981
SHUR-PATCH TAPE PATCH
K803012 · Shur Medical Corp. · Dec 1980
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · Medtronic Vascular · Dec 1979
CEPTORTRODE WITH CEPTOR HESIVE
K791097 · Med General · Aug 1979
T.E.N.S.* SINGLE-USE ELECTRODE
K790850 · 3M Company · May 1979
K800117 · TRU-PULSE PADS
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