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FDA 510(k)

THERMA-H

K-Number: K921189 · 1992-08-31

ApplicantZewa AG
Decision Date1992-08-31
Product CodeLKX
DecisionSubstantially Equivalent

Device Summary

THERMA-H is the device name listed in this FDA 510(k) record. The listed applicant is Zewa AG. It received FDA 510(k) clearance on 1992-08-31 under 510(k) number K921189. 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 1992-08-31. The listed applicant is Zewa AG. The 510(k) number is K921189.

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

THERMA-H received FDA 510(k) clearance on 1992-08-31, under 510(k) number K921189.

Who is the listed applicant for THERMA-H?

The FDA 510(k) record lists Zewa AG 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.

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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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