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FDA 510(k)

AKUFON THERAPEUTIC MASSAGER

K-Number: K850495 · 1986-01-03

ApplicantJansson A/S
Decision Date1986-01-03
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AKUFON THERAPEUTIC MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Jansson A/S. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K850495. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AKUFON THERAPEUTIC MASSAGER?

AKUFON THERAPEUTIC MASSAGER is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is Jansson A/S. The 510(k) number is K850495.

When did AKUFON THERAPEUTIC MASSAGER receive FDA 510(k) clearance?

AKUFON THERAPEUTIC MASSAGER received FDA 510(k) clearance on 1986-01-03, under 510(k) number K850495.

Who is the listed applicant for AKUFON THERAPEUTIC MASSAGER?

The FDA 510(k) record lists Jansson A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AKUFON THERAPEUTIC MASSAGER?

The FDA product code for AKUFON THERAPEUTIC MASSAGER is IRO.

Related Clinical Trials

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.

Related Devices (Code: IRO)

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.

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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