Cleared Traditional

K870568 - BIO-PROMPT(TM)

K870568 is an FDA 510(k) clearance for BIO-PROMPT(TM), manufactured by Physical Health Devices, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K870568 · Physical Health Devices, Inc. · Neurology device
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Aug 1987
Decision
175d
Days
Class 2
Risk

K870568 is an FDA 510(k) clearance for the BIO-PROMPT(TM). Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Physical Health Devices, Inc. (Miami, US). The FDA issued a Cleared decision on August 4, 1987 after a review of 175 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 Physical Health Devices, Inc. devices

FDA 510(k) Submission Details - K870568

510(k) Number K870568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date August 04, 1987
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
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 22
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K870568.
MYODAC2 BIOFEEDBACK DEVICE
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MYOTRAC
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TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
K850642 · Thought Technology , Ltd. · May 1985
HR/BVP 100T HEART RATE MONITOR
K850643 · Thought Technology , Ltd. · May 1985
CALMTONE
K834519 · Thought Technology , Ltd. · Jan 1984