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FDA 510(k)

WINDMERE PRELUDE III

K-Number: K924237 · 1993-10-18

ApplicantWindmere Corp.
Decision Date1993-10-18
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WINDMERE PRELUDE III is the device name listed in this FDA 510(k) record. The listed applicant is Windmere Corp.. It received FDA 510(k) clearance on 1993-10-18 under 510(k) number K924237. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINDMERE PRELUDE III?

WINDMERE PRELUDE III is a medical device that received FDA 510(k) clearance on 1993-10-18. The listed applicant is Windmere Corp.. The 510(k) number is K924237.

When did WINDMERE PRELUDE III receive FDA 510(k) clearance?

WINDMERE PRELUDE III received FDA 510(k) clearance on 1993-10-18, under 510(k) number K924237.

Who is the listed applicant for WINDMERE PRELUDE III?

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

What is the FDA product code for WINDMERE PRELUDE III?

The FDA product code for WINDMERE PRELUDE III is ISA.

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Other records listing Windmere Corp. 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.

K980769WINDMERE MODEL DS-2 FOOT BATHK932904WINDMERE WAND MASSAGERK933974WINDMERE MASSAGE MATEK931086WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGERK912659SOUND RELIEFK896245PLAK TRAC POWERED TOOTHBRUSH

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Related Devices (Code: ISA)

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K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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.

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