Cleared Traditional

K781964 - COMPRESSION DEVICES, LIMB
(FDA 510(k) Clearance)

K781964 · Alba-Waldensian, Inc. · Physical Medicine

Dec 1978

Decision

22d

Days

Class 2

Risk

K781964 is an FDA 510(k) clearance for the COMPRESSION DEVICES, LIMB, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Alba-Waldensian, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1978, 22 days after receiving the submission on November 20, 1978. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number	K781964 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 1978
Decision Date	December 12, 1978
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—