Cleared Traditional

K781651 - HEALTH POINT

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

FDA 510(k) Submission Details - K781651

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.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -