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)

FORCE GUARD I

K-Number: K882974 · 1988-11-04

ApplicantBoulder Impact Monitors, Inc.
Decision Date1988-11-04
Product CodeIRN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FORCE GUARD I is the device name listed in this FDA 510(k) record. The listed applicant is Boulder Impact Monitors, Inc.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K882974. The device is classified under product code IRN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORCE GUARD I?

FORCE GUARD I is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Boulder Impact Monitors, Inc.. The 510(k) number is K882974.

When did FORCE GUARD I receive FDA 510(k) clearance?

FORCE GUARD I received FDA 510(k) clearance on 1988-11-04, under 510(k) number K882974.

Who is the listed applicant for FORCE GUARD I?

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

What is the FDA product code for FORCE GUARD I?

The FDA product code for FORCE GUARD I is IRN.

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: IRN)

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.

K060150SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEMAndante Medical Devices , Ltd.K023161SMARTSTEP SYSTEMAndante Medical Device, Ltd.K991313ACCUTRED SHOEOrthopedic Technology Research, Inc.K962591FOOT WEIGHT ALARMCleveland Medical Devices, Inc.K960307INDEX SHOEOrthopedic Technology Research, Inc.K955034FORCEGUARDImpact Monitors, Inc.

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.

↑