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)

BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1

K-Number: K875103 · 1988-01-20

ApplicantShield Computers , Ltd.
Decision Date1988-01-20
Product CodeIKE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 is the device name listed in this FDA 510(k) record. The listed applicant is Shield Computers , Ltd.. It received FDA 510(k) clearance on 1988-01-20 under 510(k) number K875103. 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 BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1?

BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 is a medical device that received FDA 510(k) clearance on 1988-01-20. The listed applicant is Shield Computers , Ltd.. The 510(k) number is K875103.

When did BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 receive FDA 510(k) clearance?

BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 received FDA 510(k) clearance on 1988-01-20, under 510(k) number K875103.

Who is the listed applicant for BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1?

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

What is the FDA product code for BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1?

The FDA product code for BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 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

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.K915369THE EQUALIZERAdvanced Rehabilitative Technology, Inc.K915326PORTABLE LIMB LOAD MONITOR (BMLLM-100)Bar Med Pty , Ltd.K920091IOWA ORAL PERFORMANCE ISNTRUMENTBreakthrough, Inc.K915897FPLWrm Computers

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.

↑