Cleared Traditional

WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER

K950701 · Wahl Clipper Corp. · Physical Medicine
Mar 1995
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K950701 is an FDA 510(k) clearance for the WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER, a Pack, Heat, Moist (Class I — General Controls, product code IMA), submitted by Wahl Clipper Corp. (Steriling, US). The FDA issued a Cleared decision on March 24, 1995, 37 days after receiving the submission on February 15, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5730.

Submission Details

510(k) Number K950701 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1995
Decision Date March 24, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IMA — Pack, Heat, Moist
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5730