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FDA 510(k)

BODY WARMER (SHAKE-N-WARM)

K-Number: K760441 · 1976-09-16

ApplicantYamada Co., Ltd of Japan
Decision Date1976-09-16
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BODY WARMER (SHAKE-N-WARM) is the device name listed in this FDA 510(k) record. The listed applicant is Yamada Co., Ltd of Japan. It received FDA 510(k) clearance on 1976-09-16 under 510(k) number K760441. 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 BODY WARMER (SHAKE-N-WARM)?

BODY WARMER (SHAKE-N-WARM) is a medical device that received FDA 510(k) clearance on 1976-09-16. The listed applicant is Yamada Co., Ltd of Japan. The 510(k) number is K760441.

When did BODY WARMER (SHAKE-N-WARM) receive FDA 510(k) clearance?

BODY WARMER (SHAKE-N-WARM) received FDA 510(k) clearance on 1976-09-16, under 510(k) number K760441.

Who is the listed applicant for BODY WARMER (SHAKE-N-WARM)?

The FDA 510(k) record lists Yamada Co., Ltd of Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODY WARMER (SHAKE-N-WARM)?

The FDA product code for BODY WARMER (SHAKE-N-WARM) 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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