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)

GENTLE FEEL

K-Number: K864176 · 1986-11-04

ApplicantMali, Inc.
Decision Date1986-11-04
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENTLE FEEL is the device name listed in this FDA 510(k) record. The listed applicant is Mali, Inc.. It received FDA 510(k) clearance on 1986-11-04 under 510(k) number K864176. The device is classified under product code HFS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLE FEEL?

GENTLE FEEL is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Mali, Inc.. The 510(k) number is K864176.

When did GENTLE FEEL receive FDA 510(k) clearance?

GENTLE FEEL received FDA 510(k) clearance on 1986-11-04, under 510(k) number K864176.

Who is the listed applicant for GENTLE FEEL?

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

What is the FDA product code for GENTLE FEEL?

The FDA product code for GENTLE FEEL is HFS.

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 Mali, 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.

K855209NIR LAT MALE EXTERNAL CATHETER

Related Devices (Code: HFS)

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.

K944117AVENT NIPPLE SHIELDAvent America, Inc.K944177BREAST SHELLO'Donnell, Byrne & WilliamsK935341COMFORT PLUS BREAST SHELLSMarshall Baby ProductsK935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby ProductsK930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.K923577BREAST SHELLSMedela, 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.

↑