Cleared Traditional

K940837 - WAHL(R) FOOT COMFORT MASSAGER
(FDA 510(k) Clearance)

Jun 1994
Decision
106d
Days
Class 1
Risk

K940837 is an FDA 510(k) clearance for the WAHL(R) FOOT COMFORT MASSAGER. This device is classified as a Vibrator, Therapeutic (Class I - General Controls, product code IRO).

Submitted by Wahl Clipper Corp. (Steriling, US). The FDA issued a Cleared decision on June 9, 1994, 106 days after receiving the submission on February 23, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K940837 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 23, 1994
Decision Date June 09, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IRO — Vibrator, Therapeutic
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.5975

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