Cleared Traditional

K830316 - UNIFLEX
(FDA 510(k) Clearance)

K830316 · Buckman Consultants · Physical Medicine device

Mar 1983

Decision

52d

Days

Class 1

Risk

K830316 is an FDA 510(k) clearance for the UNIFLEX. This device is classified as a Exerciser, Powered (Class I - General Controls, product code BXB).

Submitted by Buckman Consultants (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983, 52 days after receiving the submission on January 31, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K830316 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 1983
Decision Date	March 24, 1983
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—