Cleared Traditional

INFRADERM; TOUCH 'N TONE PLUS

K911727 · Conair Corp. · Physical Medicine
Feb 1994
Decision
1045d
Days
Class 1
Risk

About This 510(k) Submission

K911727 is an FDA 510(k) clearance for the INFRADERM; TOUCH 'N TONE PLUS, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on February 25, 1994, 1045 days after receiving the submission on April 17, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K911727 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1991
Decision Date February 25, 1994
Days to Decision 1045 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660