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FDA 510(k)

SECURA BATH SEAT

K-Number: K812483 · 1981-09-14

ApplicantMaddak, Inc.
Decision Date1981-09-14
Product CodeILS
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SECURA BATH SEAT is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1981-09-14 under 510(k) number K812483. The device is classified under product code ILS. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECURA BATH SEAT?

SECURA BATH SEAT is a medical device that received FDA 510(k) clearance on 1981-09-14. The listed applicant is Maddak, Inc.. The 510(k) number is K812483.

When did SECURA BATH SEAT receive FDA 510(k) clearance?

SECURA BATH SEAT received FDA 510(k) clearance on 1981-09-14, under 510(k) number K812483.

Who is the listed applicant for SECURA BATH SEAT?

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

What is the FDA product code for SECURA BATH SEAT?

The FDA product code for SECURA BATH SEAT is ILS.

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Other records listing Maddak, 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.

K841700WALK & ROLLK841698HEAT PACKK841695CRAWLERK841693STANDING FRAMEK841697HYDRO-THERO PADK841692PRONE STANDER

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Related Devices (Code: ILS)

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.

K852049MEDICAL TOILET SEATPedro AlemanK842651COMMODE CHAIR 98200Guardian Products Co., Inc.K830853LAVATORY SEAT HEIGHTENERLic-OrthionK831547RAISED TOILET SEATS & NAIL CLIPPERSFred Sammons, Inc.K830425TOILET SEAT RAISEDMaddak, Inc.K830852SHOWER STOOL W/HANDLESLic-Orthion

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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