FDA 510(k)

AMD 6605 TENS/NMES

K-Number: K092990 · 2009-10-23

ApplicantAdvantageous Medical Devices, LLC

Decision Date2009-10-23

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AMD 6605 TENS/NMES is the device name listed in this FDA 510(k) record. The listed applicant is Advantageous Medical Devices, LLC. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K092990. 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 AMD 6605 TENS/NMES?

AMD 6605 TENS/NMES is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Advantageous Medical Devices, LLC. The 510(k) number is K092990.

When did AMD 6605 TENS/NMES receive FDA 510(k) clearance?

AMD 6605 TENS/NMES received FDA 510(k) clearance on 2009-10-23, under 510(k) number K092990.

Who is the listed applicant for AMD 6605 TENS/NMES?

The FDA 510(k) record lists Advantageous Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMD 6605 TENS/NMES?

The FDA product code for AMD 6605 TENS/NMES is GZJ.

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 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.