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FDA 510(k)

WINDMERE MODEL DS-2 FOOT BATH

K-Number: K980769 · 1998-03-27

ApplicantWindmere Corp.
Decision Date1998-03-27
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WINDMERE MODEL DS-2 FOOT BATH is the device name listed in this FDA 510(k) record. The listed applicant is Windmere Corp.. It received FDA 510(k) clearance on 1998-03-27 under 510(k) number K980769. The device is classified under product code ILJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINDMERE MODEL DS-2 FOOT BATH?

WINDMERE MODEL DS-2 FOOT BATH is a medical device that received FDA 510(k) clearance on 1998-03-27. The listed applicant is Windmere Corp.. The 510(k) number is K980769.

When did WINDMERE MODEL DS-2 FOOT BATH receive FDA 510(k) clearance?

WINDMERE MODEL DS-2 FOOT BATH received FDA 510(k) clearance on 1998-03-27, under 510(k) number K980769.

Who is the listed applicant for WINDMERE MODEL DS-2 FOOT BATH?

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 MODEL DS-2 FOOT BATH?

The FDA product code for WINDMERE MODEL DS-2 FOOT BATH is ILJ.

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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.

K932904WINDMERE WAND MASSAGERK933974WINDMERE MASSAGE MATEK924237WINDMERE PRELUDE IIIK931086WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGERK912659SOUND RELIEFK896245PLAK TRAC POWERED TOOTHBRUSH

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Related Devices (Code: ILJ)

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.

K110994PARKER 500Arjohuntleigh, Inc.K082951IMMERSION HYDROBATHArjo Hospital Equipment ABK052479MBATH 1000 (60)Enneking Medical, Inc.K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, 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.

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