Cleared Traditional

K831544 - DELUXE TRACTION EXERCISE GLOVE BK5035
(FDA 510(k) Clearance)

K831544 · Fred Sammons, Inc. · Physical Medicine
Jun 1983
Decision
43d
Days
Class 1
Risk

K831544 is an FDA 510(k) clearance for the DELUXE TRACTION EXERCISE GLOVE BK5035, a Components, Exercise (Class I — General Controls, product code IOD), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 43 days after receiving the submission on May 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5350.

Submission Details

510(k) Number K831544 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 24, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOD — Components, Exercise
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5350