Cleared Traditional

K821582 - WARM'N FORM SPORTS SUPPORTS
(FDA 510(k) Clearance)

K821582 · Jerome Medical · Physical Medicine

Jun 1982

Decision

13d

Days

Class 1

Risk

K821582 is an FDA 510(k) clearance for the WARM'N FORM SPORTS SUPPORTS. This device is classified as a Orthosis, Limb Brace (Class I — General Controls, product code IQI).

Submitted by Jerome Medical (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982, 13 days after receiving the submission on May 28, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number	K821582 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 1982
Decision Date	June 10, 1982
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—