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510(k) K832177

PULSAIR MODEL SP-1 by Thermowave Medical Device Corp. — Product Code IRQ

K832177 is an FDA 510(k) premarket notification submitted by Thermowave Medical Device Corp. for the device "PULSAIR MODEL SP-1". The FDA issued a decision of Substantially Equivalent on December 9, 1983. The device falls under product code IRQ (Unit, Heating, Powered), a Class I device regulated under 21 CFR 890.5950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1983
Date Received
July 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Heating, Powered
Device Class
Class I
Regulation Number
890.5950
Review Panel
PM
Submission Type

Other clearances for product code IRQ

  • K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (September 14, 2005)
  • K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC. (March 24, 1995)
  • K924023 — FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (April 14, 1993)
  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K861340 — R1750 AND R1424 POWERED HEATING UNITS (May 2, 1986)
  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)

FDA data resources