Cleared Traditional

K801049 - V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU

K801049 is an FDA 510(k) clearance for V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU, manufactured by Nebulae Productions. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K801049 · Nebulae Productions · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
52d
Days
Class 2
Risk

K801049 is an FDA 510(k) clearance for the V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Nebulae Productions (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980 after a review of 52 days - a notably fast clearance 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: 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 - K801049

510(k) Number K801049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1980
Decision Date June 26, 1980
Days to Decision 52 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
97d faster than avg
Panel avg: 149d · This submission: 52d
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 170
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K801049.
BIOFEEDBACK BIO 80
K803099 · Bimed, Inc. · Mar 1981
EMG-UT 30
K802390 · American Scientific Corp. · Jan 1981
EMG-UT 40
K802391 · American Scientific Corp. · Jan 1981
BIOFEEDBACK DEVICES & ACCESSORIES
K792115 · M.O.E Electronics Research & Prod. · Mar 1980
APOLLO HEART RATE INDICATOR
K791207 · Key Tronic Corp. · Aug 1979
THE BIONIC EXERCISER
K790746 · Scudder Molner Instruments · May 1979
K801049 · V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU
Download PDF Nebulae Productions