Cleared Traditional

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

K001860 · Homedics, Inc. · Physical Medicine

Aug 2000

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K001860 is an FDA 510(k) clearance for the PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA, a Bath, Paraffin (Class II — Special Controls, product code IMC), submitted by Homedics, Inc. (Commerce Township, US). The FDA issued a Cleared decision on August 10, 2000, 52 days after receiving the submission on June 19, 2000. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number	K001860 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2000
Decision Date	August 10, 2000
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF