510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832177Substantially Equivalent

Pulsair Model Sp-1

Thermowave Medical Device Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832177 is the FDA 510(k) clearance record for PULSAIR MODEL SP-1, a class I device, cleared for Thermowave Medical Device Corp. on under FDA product code IRQ (Unit, Heating, Powered). FDA records list one 510(k) clearance for Thermowave Medical Device Corp. As of , FDA records show no recalls naming K832177.

Clearance record

Decision date
Received
(156 days to decision)
Product code
IRQ Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Thermowave Medical Device Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code IRQ

Trailing 12 months

FDA records hold no clearances under product code IRQ in the trailing twelve months.

FDA records show no clearances under product code IRQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IRQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260