FDA 510(k)

TENS-EMS-14

K-Number: K083030 · 2009-02-05

ApplicantEmsi

Decision Date2009-02-05

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TENS-EMS-14 is the device name listed in this FDA 510(k) record. The listed applicant is Emsi. It received FDA 510(k) clearance on 2009-02-05 under 510(k) number K083030. 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-EMS-14?

TENS-EMS-14 is a medical device that received FDA 510(k) clearance on 2009-02-05. The listed applicant is Emsi. The 510(k) number is K083030.

When did TENS-EMS-14 receive FDA 510(k) clearance?

TENS-EMS-14 received FDA 510(k) clearance on 2009-02-05, under 510(k) number K083030.

Who is the listed applicant for TENS-EMS-14?

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

What is the FDA product code for TENS-EMS-14?

The FDA product code for TENS-EMS-14 is GZJ.

Other records listing Emsi 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.

K102202GS 3000 K090889EMSI GARMENT ELECTRODES K090717FLEX-TENS K071869TENS/IF 14

Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical 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.