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FDA 510(k)

THERMA-H

K-Number: K905276 · 1991-11-07

ApplicantKure Swiss Medical AG Corp.
Decision Date1991-11-07
Product CodeLKX
DecisionSubstantially Equivalent

Device Summary

THERMA-H is the device name listed in this FDA 510(k) record. The listed applicant is Kure Swiss Medical AG Corp.. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K905276. The device is classified under product code LKX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMA-H?

THERMA-H is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Kure Swiss Medical AG Corp.. The 510(k) number is K905276.

When did THERMA-H receive FDA 510(k) clearance?

THERMA-H received FDA 510(k) clearance on 1991-11-07, under 510(k) number K905276.

Who is the listed applicant for THERMA-H?

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

What is the FDA product code for THERMA-H?

The FDA product code for THERMA-H is LKX.

Related Clinical Trials

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Related Devices (Code: LKX)

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.

K172358InstaliefPrivi Medical Pte, Ltd.K113660COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALCryotherapy Products, Inc.K072414CRYOSTATLil Drug Store Products, Inc.K042564HEMOR-RITE CRYOTHERAPHYFama Holdings International CorpK012746ICE BATONBehive, Ltd.K981428ANU ICECryoptherapy Pain Relief Products, 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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