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)

HANDIFLEX

K-Number: K971046 · 1997-09-16

ApplicantHandiflex Corp.
Decision Date1997-09-16
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HANDIFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Handiflex Corp.. It received FDA 510(k) clearance on 1997-09-16 under 510(k) number K971046. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDIFLEX?

HANDIFLEX is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Handiflex Corp.. The 510(k) number is K971046.

When did HANDIFLEX receive FDA 510(k) clearance?

HANDIFLEX received FDA 510(k) clearance on 1997-09-16, under 510(k) number K971046.

Who is the listed applicant for HANDIFLEX?

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

What is the FDA product code for HANDIFLEX?

The FDA product code for HANDIFLEX is JFB.

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: JFB)

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.

K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas JorgeK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., 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.

↑