Cleared Traditional

K781647 - BACK TRAC

K781647 is an FDA 510(k) clearance for BACK TRAC, manufactured by Tech Engineering, Inc.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K781647 · Tech Engineering, Inc. · Neurology device
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Oct 1978
Decision
20d
Days
Class 1
Risk

K781647 is an FDA 510(k) clearance for the BACK TRAC. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Tech Engineering, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - 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 - K781647

510(k) Number K781647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1978
Decision Date October 17, 1978
Days to Decision 20 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
129d faster than avg
Panel avg: 149d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HST Apparatus, Traction, Non-powered

All 37
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K781647.
MEDI-TRAK PORTABLE TRACTION DEVICE
K791396 · Medicorp, Inc. · Aug 1979
OCTAGONAL ALUMINUM FRAMING SYSTEM
K790729 · Orthopedic Systems, Inc. · May 1979
VERTETRAC
K771988 · Ballert Orthopedic Corp. · Feb 1979
TRACTION UNITS
K780228 · Biomet, Inc. · Feb 1978
TRACTION WEIGHT BAGS
K780233 · Biomet, Inc. · Feb 1978
BAKER MOBILE TRACTION
K770080 · Orthopedic Equipment Co., Inc. · Jan 1977
K781647 · BACK TRAC
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