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FDA 510(k)

EA STIMULATOR

K-Number: K080221 · 2008-09-09

ApplicantHelio Medical Supplies, Inc.
Decision Date2008-09-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EA STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Helio Medical Supplies, Inc.. It received FDA 510(k) clearance on 2008-09-09 under 510(k) number K080221. 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 EA STIMULATOR?

EA STIMULATOR is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Helio Medical Supplies, Inc.. The 510(k) number is K080221.

When did EA STIMULATOR receive FDA 510(k) clearance?

EA STIMULATOR received FDA 510(k) clearance on 2008-09-09, under 510(k) number K080221.

Who is the listed applicant for EA STIMULATOR?

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

What is the FDA product code for EA STIMULATOR?

The FDA product code for EA STIMULATOR is GZJ.

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Other records listing Helio Medical Supplies, Inc. as applicant

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Related Devices (Code: GZJ)

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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.

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