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FDA 510(k)

ALLY PORTABLE NOT PACK/PAD DISPOSABLE

K-Number: K853045 · 1985-09-06

ApplicantActin International, Inc.
Decision Date1985-09-06
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALLY PORTABLE NOT PACK/PAD DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Actin International, Inc.. It received FDA 510(k) clearance on 1985-09-06 under 510(k) number K853045. 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 ALLY PORTABLE NOT PACK/PAD DISPOSABLE?

ALLY PORTABLE NOT PACK/PAD DISPOSABLE is a medical device that received FDA 510(k) clearance on 1985-09-06. The listed applicant is Actin International, Inc.. The 510(k) number is K853045.

When did ALLY PORTABLE NOT PACK/PAD DISPOSABLE receive FDA 510(k) clearance?

ALLY PORTABLE NOT PACK/PAD DISPOSABLE received FDA 510(k) clearance on 1985-09-06, under 510(k) number K853045.

Who is the listed applicant for ALLY PORTABLE NOT PACK/PAD DISPOSABLE?

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

What is the FDA product code for ALLY PORTABLE NOT PACK/PAD DISPOSABLE?

The FDA product code for ALLY PORTABLE NOT PACK/PAD DISPOSABLE 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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