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)

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001

K-Number: K020592 · 2002-04-03

ApplicantAlba-Waldensian, Inc.
Decision Date2002-04-03
Product CodeDWL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 is the device name listed in this FDA 510(k) record. The listed applicant is Alba-Waldensian, Inc.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020592. The device is classified under product code DWL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001?

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Alba-Waldensian, Inc.. The 510(k) number is K020592.

When did ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 receive FDA 510(k) clearance?

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020592.

Who is the listed applicant for ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001?

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

What is the FDA product code for ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001?

The FDA product code for ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 is DWL.

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 Alba-Waldensian, 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.

K961405ALBA HEALTH PAS WRAP SYSTEMK852091ALBA DRY BURN PADK792357STERILE IMPERVIOUS ORTHOPEDIC STOCKINK781964COMPRESSION DEVICES, LIMBK780570TUBULAR DRESSING RETAINERK780547STERILE ORTHOPEDIC STOCKINETTE

View all 8 devices →

Related Devices (Code: DWL)

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.

K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)Bsn Medical, Inc.K122485ENCIRCLE COMPRESSION THERAPY STOCKINGEncircle Medical Devices , Ltd.K123820BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOSBossong Hosiery Mills, Inc.K123085FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE3M CompanyK123398DR. SCHOLL'S COMPRESSION SOCKSRenfro CorporationK123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSBsn Medical, 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.

↑