Cleared Traditional

DIGIT-GRIP WITH LCD (DGR002) (K970870) - FDA 510(k) Clearance

Class I Neurology device.

K970870 · Nk Biotechnical Corp. · Neurology device
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May 1997
Decision
53d
Days
Class 1
Risk

K970870 is an FDA 510(k) clearance for the DIGIT-GRIP WITH LCD (DGR002). Classified as Dynamometer, Nonpowered (product code HRW), Class I - General Controls.

Submitted by Nk Biotechnical Corp. (Minneapolis, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1250 - 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 Nk Biotechnical Corp. devices

Submission Details

510(k) Number K970870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date May 02, 1997
Days to Decision 53 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 148d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRW Dynamometer, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1250
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 - HRW Dynamometer, Nonpowered

All 11
Devices cleared under the same product code (HRW) and FDA review panel - the closest regulatory comparables to K970870.
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