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FDA 510(k)

WONDER WARMER

K-Number: K810633 · 1981-03-26

ApplicantMontvale Products, Inc.
Decision Date1981-03-26
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WONDER WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Montvale Products, Inc.. It received FDA 510(k) clearance on 1981-03-26 under 510(k) number K810633. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WONDER WARMER?

WONDER WARMER is a medical device that received FDA 510(k) clearance on 1981-03-26. The listed applicant is Montvale Products, Inc.. The 510(k) number is K810633.

When did WONDER WARMER receive FDA 510(k) clearance?

WONDER WARMER received FDA 510(k) clearance on 1981-03-26, under 510(k) number K810633.

Who is the listed applicant for WONDER WARMER?

The FDA 510(k) record lists Montvale Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WONDER WARMER?

The FDA product code for WONDER WARMER is IMD.

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Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.

Official Source

View on FDA Database →

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

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