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FDA 510(k)

ULTIMA XS (TENS)

K-Number: K880751 · 1988-04-06

ApplicantAmerican Imex
Decision Date1988-04-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTIMA XS (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is American Imex. It received FDA 510(k) clearance on 1988-04-06 under 510(k) number K880751. 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 ULTIMA XS (TENS)?

ULTIMA XS (TENS) is a medical device that received FDA 510(k) clearance on 1988-04-06. The listed applicant is American Imex. The 510(k) number is K880751.

When did ULTIMA XS (TENS) receive FDA 510(k) clearance?

ULTIMA XS (TENS) received FDA 510(k) clearance on 1988-04-06, under 510(k) number K880751.

Who is the listed applicant for ULTIMA XS (TENS)?

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

What is the FDA product code for ULTIMA XS (TENS)?

The FDA product code for ULTIMA XS (TENS) is GZJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Imex 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.

K032003PREMIER PLUSK982221PREMIER APK926326MICROCARE(TM)K912289ULTIMA XS, MODIFICATIONK895295ULTIMA XS MICROCURRENT TENSK894388ZIMMER TENS

View all 11 devices →

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 miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical 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.

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