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FDA 510(k)

ALPHA-STIM 350

K-Number: K831145 · 1983-07-07

ApplicantElectromedical Products, Inc.
Decision Date1983-07-07
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALPHA-STIM 350 is the device name listed in this FDA 510(k) record. The listed applicant is Electromedical Products, Inc.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831145. 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 ALPHA-STIM 350?

ALPHA-STIM 350 is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Electromedical Products, Inc.. The 510(k) number is K831145.

When did ALPHA-STIM 350 receive FDA 510(k) clearance?

ALPHA-STIM 350 received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831145.

Who is the listed applicant for ALPHA-STIM 350?

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

What is the FDA product code for ALPHA-STIM 350?

The FDA product code for ALPHA-STIM 350 is GZJ.

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.

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Other records listing Electromedical Products, Inc. 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.

K903014ALPHA-STIM CSK896948ALPHA-STIM CSK881753ALPHA-STIM 350K831144ALPHA-STIM 2000

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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