FDA 510(k)

E-STIM II

K-Number: K050435 · 2005-09-06

Decision Date2005-09-06

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

E-STIM II is the device name listed in this FDA 510(k) record. The listed applicant is Lhasa Oms, Inc.. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K050435. 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 E-STIM II?

E-STIM II is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is Lhasa Oms, Inc.. The 510(k) number is K050435.

When did E-STIM II receive FDA 510(k) clearance?

E-STIM II received FDA 510(k) clearance on 2005-09-06, under 510(k) number K050435.

Who is the listed applicant for E-STIM II?

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

What is the FDA product code for E-STIM II?

The FDA product code for E-STIM II is GZJ.

Other records listing Lhasa Oms, 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.

K200636AXUS ES-5 Electro-Acupuncture Device K062003NEURO WAVE 6 K060508POINTER PLUS K060517POINTER EXCEL K061080IR PRO 250 K050989AWQ-104

View all 8 devices →

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.