Cleared Traditional

FOOT BATHS & HAND MASSAGERS

K810034 · Associated Mills, Inc. · Physical Medicine
Jan 1981
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K810034 is an FDA 510(k) clearance for the FOOT BATHS & HAND MASSAGERS, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Associated Mills, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981, 9 days after receiving the submission on January 6, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K810034 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1981
Decision Date January 15, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILJ — Bath, Hydro-massage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5100