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FDA 510(k)

TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804

K-Number: K853718 · 1985-12-04

ApplicantElectro Therapeutic Devices, Inc.
Decision Date1985-12-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 is the device name listed in this FDA 510(k) record. The listed applicant is Electro Therapeutic Devices, Inc.. It received FDA 510(k) clearance on 1985-12-04 under 510(k) number K853718. 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 TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804?

TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 is a medical device that received FDA 510(k) clearance on 1985-12-04. The listed applicant is Electro Therapeutic Devices, Inc.. The 510(k) number is K853718.

When did TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 receive FDA 510(k) clearance?

TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 received FDA 510(k) clearance on 1985-12-04, under 510(k) number K853718.

Who is the listed applicant for TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804?

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

What is the FDA product code for TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804?

The FDA product code for TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 is GZJ.

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Other records listing Electro Therapeutic Devices, Inc. as applicant

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K981272ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLESK875317ELECTRICAL MUSCLE STIMULATOR MODEL MYOAIDK863568'MYOSTIM EX'K863567'TENSAID'K853719TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410K843119ETI TENS BELT

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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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