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)

STRESS HANDLER

K-Number: K936148 · 1994-04-21

ApplicantArocep Enterprises , Ltd.
Decision Date1994-04-21
Product CodeLYG
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

STRESS HANDLER is the device name listed in this FDA 510(k) record. The listed applicant is Arocep Enterprises , Ltd.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K936148. The device is classified under product code LYG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the STRESS HANDLER?

STRESS HANDLER is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Arocep Enterprises , Ltd.. The 510(k) number is K936148.

When did STRESS HANDLER receive FDA 510(k) clearance?

STRESS HANDLER received FDA 510(k) clearance on 1994-04-21, under 510(k) number K936148.

Who is the listed applicant for STRESS HANDLER?

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

What is the FDA product code for STRESS HANDLER?

The FDA product code for STRESS HANDLER is LYG.

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: LYG)

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.

K963704MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGEShippert Medical Technologies Corp.K936312MANUAL MASSAGE ROLLERMckenna & CuneoK952043BACK MASSAGEREight Corners, Inc.K930613HOOKING SYSTEMAlain MachtelinckxK924315THE MASSAGERFour DirectionsK922366SPINE LINEDambrecine, 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.

↑