Cleared Traditional

PULSAIR MODEL SP-1 (K832177) - FDA 510(k) Clearance

Class I Physical Medicine device.

K832177 · Thermowave Medical Device Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
156d
Days
Class 1
Risk

K832177 is an FDA 510(k) clearance for the PULSAIR MODEL SP-1. Classified as Unit, Heating, Powered (product code IRQ), Class I - General Controls.

Submitted by Thermowave Medical Device Corp. (Walker, US). The FDA issued a Cleared decision on December 9, 1983 after a review of 156 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5950 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermowave Medical Device Corp. devices

Submission Details

510(k) Number K832177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRQ Unit, Heating, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.