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FDA 510(k)

PULSAIR MODEL SP-1

K-Number: K832177 · 1983-12-09

ApplicantThermowave Medical Device Corp.
Decision Date1983-12-09
Product CodeIRQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PULSAIR MODEL SP-1 is the device name listed in this FDA 510(k) record. The listed applicant is Thermowave Medical Device Corp.. It received FDA 510(k) clearance on 1983-12-09 under 510(k) number K832177. The device is classified under product code IRQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSAIR MODEL SP-1?

PULSAIR MODEL SP-1 is a medical device that received FDA 510(k) clearance on 1983-12-09. The listed applicant is Thermowave Medical Device Corp.. The 510(k) number is K832177.

When did PULSAIR MODEL SP-1 receive FDA 510(k) clearance?

PULSAIR MODEL SP-1 received FDA 510(k) clearance on 1983-12-09, under 510(k) number K832177.

Who is the listed applicant for PULSAIR MODEL SP-1?

The FDA 510(k) record lists Thermowave Medical Device Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSAIR MODEL SP-1?

The FDA product code for PULSAIR MODEL SP-1 is IRQ.

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Related Devices (Code: IRQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050524EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000Marda Medical, Inc.K950350THEMALATOR. MODELS T-4-S, T-8-S, ETC.Whitehall/Div Columbus Mckennon Corp.K924023FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917FernoK880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)Fred Sammons, Inc.K861340R1750 AND R1424 POWERED HEATING UNITSTri W-G, Inc.K801625THERMOLATOR HEATING UNITTru-Eze Mfg. Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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