FDA 510(k)

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR

K-Number: K090922 · 2009-06-05

ApplicantEmpi

Decision Date2009-06-05

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K090922. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR?

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Empi. The 510(k) number is K090922.

When did EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR receive FDA 510(k) clearance?

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR received FDA 510(k) clearance on 2009-06-05, under 510(k) number K090922.

Who is the listed applicant for EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR?

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

What is the FDA product code for EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR?

The FDA product code for EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR is GZJ.

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Other records listing Empi as applicant

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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.