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)

MAXIMA I

K-Number: K931424 · 1993-06-04

ApplicantStaodyne, Inc.
Decision Date1993-06-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAXIMA I is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1993-06-04 under 510(k) number K931424. 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 MAXIMA I?

MAXIMA I is a medical device that received FDA 510(k) clearance on 1993-06-04. The listed applicant is Staodyne, Inc.. The 510(k) number is K931424.

When did MAXIMA I receive FDA 510(k) clearance?

MAXIMA I received FDA 510(k) clearance on 1993-06-04, under 510(k) number K931424.

Who is the listed applicant for MAXIMA I?

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

What is the FDA product code for MAXIMA I?

The FDA product code for MAXIMA I 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 Staodyne, 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.

K952680VARAPULSE-2K941923STERILE TREATMENT ELECTRODEK931925TPK CUTANEOUS ELECTRODEK926510STAODYN EMS+2K930865STAODYN MAXIMA IIIK925898MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS

View all 9 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.

↑