THUMPER (VIBRATOR/MASSAGER)— 510(k) K860159

Name: FDA 510(k) clearance K860159
Creator: U.S. Food and Drug Administration
Published: 1986-02-06

Substantially Equivalent

Wellness Innovations Corp.

FDA 510(k) clearance K860159 for THUMPER (VIBRATOR/MASSAGER), Substantially Equivalent on 1986-02-06. Applicant: Wellness Innovations Corp.. Device class: 1.

Clearance details

Applicant: Wellness Innovations Corp.
Product code: Code IRO
Device class: Class 1
Regulation: 21 CFR 890.5975
Advisory panel: Physical Medicine
Date received: 1986-01-16
Decision date: 1986-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L3r 4b5, CA

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