Cleared Traditional

K832177 - PULSAIR MODEL SP-1

K832177 is an FDA 510(k) clearance for PULSAIR MODEL SP-1, manufactured by Thermowave Medical Device Corp.. The device is a Class 1 Physical Medicine device with product code IRQ cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K832177 · Thermowave Medical Device Corp. · Physical Medicine device
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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

FDA 510(k) Submission Details - K832177

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.

IRQ Device Classification - Class 1, General Controls

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.