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FDA 510(k)

TENS

K-Number: K921110 · 1992-08-14

ApplicantStaodyne, Inc.
Decision Date1992-08-14
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1992-08-14 under 510(k) number K921110. 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 TENS?

TENS is a medical device that received FDA 510(k) clearance on 1992-08-14. The listed applicant is Staodyne, Inc.. The 510(k) number is K921110.

When did TENS receive FDA 510(k) clearance?

TENS received FDA 510(k) clearance on 1992-08-14, under 510(k) number K921110.

Who is the listed applicant for TENS?

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

What is the FDA product code for TENS?

The FDA product code for TENS is GZJ.

Related PubMed Literature

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.

PMID: 34499554Focal High-Intensity Focused Ultrasound Ablation of the Prostate.Journal of endourology ()PMID: 29060903Development of evaluation methods for the approval and review of Intense pulsed light (IPL).Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference ()

Other records listing Staodyne, 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.

K952680VARAPULSE-2K941923STERILE TREATMENT ELECTRODEK931925TPK CUTANEOUS ELECTRODEK926510STAODYN EMS+2K931424MAXIMA IK930865STAODYN MAXIMA III

View all 9 devices →

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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