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FDA 510(k)

ANASTIM II TRANSCUTANEOUS ELECTRICAL

K-Number: K802227 · 1980-09-26

ApplicantBiostim, Inc.
Decision Date1980-09-26
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ANASTIM II TRANSCUTANEOUS ELECTRICAL is the device name listed in this FDA 510(k) record. The listed applicant is Biostim, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802227. 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 ANASTIM II TRANSCUTANEOUS ELECTRICAL?

ANASTIM II TRANSCUTANEOUS ELECTRICAL is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Biostim, Inc.. The 510(k) number is K802227.

When did ANASTIM II TRANSCUTANEOUS ELECTRICAL receive FDA 510(k) clearance?

ANASTIM II TRANSCUTANEOUS ELECTRICAL received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802227.

Who is the listed applicant for ANASTIM II TRANSCUTANEOUS ELECTRICAL?

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

What is the FDA product code for ANASTIM II TRANSCUTANEOUS ELECTRICAL?

The FDA product code for ANASTIM II TRANSCUTANEOUS ELECTRICAL is GZJ.

Related Clinical Trials

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Other records listing Biostim, 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.

K844023AQUAFORM ELECTRODES WITH AQUAPOREK840725CLINICAL CARE STIMULATORK840724MUSCLE STIMULATOR X-10K820678SYSTEM 10

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

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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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