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FDA 510(k)

ETI TENS BELT

K-Number: K843119 · 1984-08-17

ApplicantElectro Therapeutic Devices, Inc.
Decision Date1984-08-17
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ETI TENS BELT 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 1984-08-17 under 510(k) number K843119. 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 ETI TENS BELT?

ETI TENS BELT is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Electro Therapeutic Devices, Inc.. The 510(k) number is K843119.

When did ETI TENS BELT receive FDA 510(k) clearance?

ETI TENS BELT received FDA 510(k) clearance on 1984-08-17, under 510(k) number K843119.

Who is the listed applicant for ETI TENS BELT?

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 ETI TENS BELT?

The FDA product code for ETI TENS BELT is GZJ.

Other records listing Electro Therapeutic Devices, 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.

K981272ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLESK875317ELECTRICAL MUSCLE STIMULATOR MODEL MYOAIDK863568'MYOSTIM EX'K863567'TENSAID'K853719TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410K853718TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804

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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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