Cleared Traditional

K964933 - MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)

K964933 is an FDA 510(k) clearance for MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG), manufactured by Mekanika, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K964933 · Mekanika, Inc. · Neurology device
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Feb 1997
Decision
55d
Days
Class 2
Risk

K964933 is an FDA 510(k) clearance for the MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG). Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Mekanika, Inc. (Miami, US). The FDA issued a Cleared decision on February 3, 1997 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - 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.

View all Mekanika, Inc. devices

FDA 510(k) Submission Details - K964933

510(k) Number K964933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1996
Decision Date February 03, 1997
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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 - LBB Dynamometer, Ac-powered

All 7
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K964933.
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