Cleared Traditional

K930634 - SUR FLO THERMAL THERAPY PADS
(FDA 510(k) Clearance)

K930634 · Buckman Co., Inc. · Physical Medicine
Nov 1993
Decision
266d
Days
Class 2
Risk

K930634 is an FDA 510(k) clearance for the SUR FLO THERMAL THERAPY PADS. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II — Special Controls, product code ILO).

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on November 1, 1993, 266 days after receiving the submission on February 8, 1993.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.

Submission Details

510(k) Number K930634 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1993
Decision Date November 01, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ILO — Pack, Hot Or Cold, Water Circulating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5720