Cleared Traditional

K894840 - MYODAC2 BIOFEEDBACK DEVICE

K894840 is an FDA 510(k) clearance for MYODAC2 BIOFEEDBACK DEVICE, manufactured by Thought Technology , Ltd.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K894840 · Thought Technology , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
85d
Days
Class 2
Risk

K894840 is an FDA 510(k) clearance for the MYODAC2 BIOFEEDBACK DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on October 13, 1989 after a review of 85 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 - K894840

510(k) Number K894840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date October 13, 1989
Days to Decision 85 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
64d faster than avg
Panel avg: 149d · This submission: 85d
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 172
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K894840.
ELT OR ERGONOMIC LIFT TRAINER
K890500 · Physical Health Devices, Inc. · Jan 1990
VERIMED MYOEXORCISER III (MYO III)
K892649 · Verimed Holdings, Inc. · Dec 1989
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
K892114 · Eclosion, Inc. · Oct 1989
AUTOMATED THERAPY SYSTEM
K891693 · Harding & Harris, Inc. · Aug 1989
LEUNOMED RFB 5000
K881164 · Hemodynamics, Inc. · Apr 1989
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
K884849 · Moe · Mar 1989
K894840 · MYODAC2 BIOFEEDBACK DEVICE
Download PDF Thought Technology , …