Cleared Traditional

K951213 - RELAXPLUS

K951213 is an FDA 510(k) clearance for RELAXPLUS, manufactured by Ultramind International , Ltd.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K951213 · Ultramind International , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
187d
Days
Class 2
Risk

K951213 is an FDA 510(k) clearance for the RELAXPLUS. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Ultramind International , Ltd. (Eilat, IL). The FDA issued a Cleared decision on September 20, 1995 after a review of 187 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Ultramind International , Ltd. devices

FDA 510(k) Submission Details - K951213

510(k) Number K951213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1995
Decision Date September 20, 1995
Days to Decision 187 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 148d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 43
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K951213.
AT53 DUAL CHANNEL EMG
K952797 · Stoelting Co. · Apr 1996
DIGITAL CONDUCTANCE METER
K924313 · The Jayms Co. · Mar 1996
ORALSENSOR
K953257 · Cycura Corp. · Feb 1996
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995
MYOTRAC2
K915858 · Thought Technology , Ltd. · Sep 1992
MYOTRAC/S, MYODAC/S
K915859 · Thought Technology , Ltd. · Sep 1992