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FDA 510(k)

SINUS AC-POWERED MUSCLE STIMULATOR

K-Number: K850453 · 1985-05-07

Decision Date1985-05-07
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SINUS AC-POWERED MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Elektromedizin GmbH. It received FDA 510(k) clearance on 1985-05-07 under 510(k) number K850453. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINUS AC-POWERED MUSCLE STIMULATOR?

SINUS AC-POWERED MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1985-05-07. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K850453.

When did SINUS AC-POWERED MUSCLE STIMULATOR receive FDA 510(k) clearance?

SINUS AC-POWERED MUSCLE STIMULATOR received FDA 510(k) clearance on 1985-05-07, under 510(k) number K850453.

Who is the listed applicant for SINUS AC-POWERED MUSCLE STIMULATOR?

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

What is the FDA product code for SINUS AC-POWERED MUSCLE STIMULATOR?

The FDA product code for SINUS AC-POWERED MUSCLE STIMULATOR is IPF.

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.

Other records listing Zimmer Elektromedizin GmbH as applicant

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.

View all 12 devices →

Related Devices (Code: IPF)

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

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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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