Cleared Traditional

HEALTH POINT (K781651) - FDA 510(k) Clearance

K781651 · Anritsu America Co. · Neurology device
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Apr 1979
Decision
188d
Days
-
Risk

K781651 is an FDA 510(k) clearance for the HEALTH POINT. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Anritsu America Co. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 188 days - an extended review cycle.

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. Standard predicate reliance. 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 Anritsu America Co. devices

Submission Details

510(k) Number K781651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1978
Decision Date April 03, 1979
Days to Decision 188 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 148d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -