FDA 510(k)

STEAM PAK MOIST HEAT

K-Number: K832803 · 1983-09-20

ApplicantElectro-Med Health Industries, Inc.

Decision Date1983-09-20

Product CodeIMA

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

STEAM PAK MOIST HEAT is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Med Health Industries, Inc.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832803. The device is classified under product code IMA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEAM PAK MOIST HEAT?

STEAM PAK MOIST HEAT is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Electro-Med Health Industries, Inc.. The 510(k) number is K832803.

When did STEAM PAK MOIST HEAT receive FDA 510(k) clearance?

STEAM PAK MOIST HEAT received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832803.

Who is the listed applicant for STEAM PAK MOIST HEAT?

The FDA 510(k) record lists Electro-Med Health Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEAM PAK MOIST HEAT?

The FDA product code for STEAM PAK MOIST HEAT is IMA.

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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.