Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEPAX (TENS)

K-Number: K882154 · 1988-09-30

ApplicantAvl Scientific Corp.
Decision Date1988-09-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEPAX (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Avl Scientific Corp.. It received FDA 510(k) clearance on 1988-09-30 under 510(k) number K882154. 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 HEPAX (TENS)?

HEPAX (TENS) is a medical device that received FDA 510(k) clearance on 1988-09-30. The listed applicant is Avl Scientific Corp.. The 510(k) number is K882154.

When did HEPAX (TENS) receive FDA 510(k) clearance?

HEPAX (TENS) received FDA 510(k) clearance on 1988-09-30, under 510(k) number K882154.

Who is the listed applicant for HEPAX (TENS)?

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

What is the FDA product code for HEPAX (TENS)?

The FDA product code for HEPAX (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 Avl Scientific Corp. 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.

K001632OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009K000103AVL OPTI R ANALYZERK993837AVL OPTI CRITICAL CARE ANALYZERK990092AVL OMNI MODULAR ANALYZERK984299AVL OPTI CRITICAL CARE ANALYZERK974784AVL OPTI CRITICAL CARE ANALYZER

View all 33 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.

↑