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FDA 510(k)

SELF HEATING DISPOSABLE HEAT PAD

K-Number: K811206 · 1981-05-21

ApplicantEnsar Corp.
Decision Date1981-05-21
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SELF HEATING DISPOSABLE HEAT PAD is the device name listed in this FDA 510(k) record. The listed applicant is Ensar Corp.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811206. 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 SELF HEATING DISPOSABLE HEAT PAD?

SELF HEATING DISPOSABLE HEAT PAD is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Ensar Corp.. The 510(k) number is K811206.

When did SELF HEATING DISPOSABLE HEAT PAD receive FDA 510(k) clearance?

SELF HEATING DISPOSABLE HEAT PAD received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811206.

Who is the listed applicant for SELF HEATING DISPOSABLE HEAT PAD?

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

What is the FDA product code for SELF HEATING DISPOSABLE HEAT PAD?

The FDA product code for SELF HEATING DISPOSABLE HEAT PAD 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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