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FDA 510(k)

MASSAGING HELMET C.F. HANSEN DESIGN

K-Number: K940582 · 1995-01-30

ApplicantPhilco Ushuaia
Decision Date1995-01-30
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

MASSAGING HELMET C.F. HANSEN DESIGN is the device name listed in this FDA 510(k) record. The listed applicant is Philco Ushuaia. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K940582. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MASSAGING HELMET C.F. HANSEN DESIGN?

MASSAGING HELMET C.F. HANSEN DESIGN is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Philco Ushuaia. The 510(k) number is K940582.

When did MASSAGING HELMET C.F. HANSEN DESIGN receive FDA 510(k) clearance?

MASSAGING HELMET C.F. HANSEN DESIGN received FDA 510(k) clearance on 1995-01-30, under 510(k) number K940582.

Who is the listed applicant for MASSAGING HELMET C.F. HANSEN DESIGN?

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

What is the FDA product code for MASSAGING HELMET C.F. HANSEN DESIGN?

The FDA product code for MASSAGING HELMET C.F. HANSEN DESIGN is IRO.

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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.

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Official Source

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

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