Cleared Traditional

PULSAIR MODEL SP-1

K832177 · Thermowave Medical Device Corp. · Physical Medicine

Dec 1983

Decision

156d

Days

Class 1

Risk

About This 510(k) Submission

K832177 is an FDA 510(k) clearance for the PULSAIR MODEL SP-1, a Unit, Heating, Powered (Class I — General Controls, product code IRQ), submitted by Thermowave Medical Device Corp. (Walker, US). The FDA issued a Cleared decision on December 9, 1983, 156 days after receiving the submission on July 6, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K832177 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 1983
Decision Date	December 09, 1983
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—