Cleared Traditional

K850006 - TENS

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.

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FDA 510(k) Submission Details - K850006

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 - Class ,

Product Code -
Device Class -