FDA 510(k)

MED-TENS

K-Number: K921813 · 1992-09-11

Decision Date1992-09-11

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MED-TENS is the device name listed in this FDA 510(k) record. The listed applicant is Ems Dist.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K921813. 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 MED-TENS?

MED-TENS is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Ems Dist.. The 510(k) number is K921813.

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

MED-TENS received FDA 510(k) clearance on 1992-09-11, under 510(k) number K921813.

Who is the listed applicant for MED-TENS?

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

What is the FDA product code for MED-TENS?

The FDA product code for MED-TENS is GZJ.

Other records listing Ems Dist. 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.

K931570COM-TENS (SINGLE MODE)K812984SLIMTRONICS 2000

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.