Cleared Traditional

TENS (K850006) - FDA 510(k) Clearance

K850006 · Zimmer Elektromedizin GmbH · Neurology device
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Dec 1985
Decision
352d
Days
-
Risk

K850006 is an FDA 510(k) clearance for the TENS.

Submitted by Zimmer Elektromedizin GmbH (7910 Neu-Ulm, Germany, DE). The FDA issued a Cleared decision on December 20, 1985 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer Elektromedizin GmbH devices

Submission Details

510(k) Number K850006 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 02, 1985
Decision Date December 20, 1985
Days to Decision 352 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 148d · This submission: 352d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -