FDA 510(k)

FLEX-TENS

K-Number: K090717 · 2009-05-08

ApplicantEmsi

Decision Date2009-05-08

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FLEX-TENS is the device name listed in this FDA 510(k) record. The listed applicant is Emsi. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K090717. 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 FLEX-TENS?

FLEX-TENS is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Emsi. The 510(k) number is K090717.

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

FLEX-TENS received FDA 510(k) clearance on 2009-05-08, under 510(k) number K090717.

Who is the listed applicant for FLEX-TENS?

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 FLEX-TENS?

The FDA product code for FLEX-TENS 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 K083030TENS-EMS-14 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.