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)

THE EQUALIZER

K-Number: K915369 · 1993-03-22

ApplicantAdvanced Rehabilitative Technology, Inc.
Decision Date1993-03-22
Product CodeIKE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE EQUALIZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Rehabilitative Technology, Inc.. It received FDA 510(k) clearance on 1993-03-22 under 510(k) number K915369. The device is classified under product code IKE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE EQUALIZER?

THE EQUALIZER is a medical device that received FDA 510(k) clearance on 1993-03-22. The listed applicant is Advanced Rehabilitative Technology, Inc.. The 510(k) number is K915369.

When did THE EQUALIZER receive FDA 510(k) clearance?

THE EQUALIZER received FDA 510(k) clearance on 1993-03-22, under 510(k) number K915369.

Who is the listed applicant for THE EQUALIZER?

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

What is the FDA product code for THE EQUALIZER?

The FDA product code for THE EQUALIZER is IKE.

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 Advanced Rehabilitative Technology, 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.

K912328ELECTRONIC MUSCLE STIMULATORS, EXCEL II, MODIFIEDK903711RHEOLOGIC I

Related Devices (Code: IKE)

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.

K060125SONIC PALPOMETERPalpometer Systems, Inc.K954670PRESSORE MONITORCleveland Medical Devices, Inc.K915326PORTABLE LIMB LOAD MONITOR (BMLLM-100)Bar Med Pty , Ltd.K920091IOWA ORAL PERFORMANCE ISNTRUMENTBreakthrough, Inc.K915897FPLWrm ComputersK914780TALLEY SD.500 SKIN PRESSURE EVALUATORTalley Group, Ltd.

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.

↑