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FDA 510(k)

SHOWER STOOL W/HANDLES

K-Number: K823154 · 1982-11-05

ApplicantOrthion Corp.
Decision Date1982-11-05
Product CodeIKX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SHOWER STOOL W/HANDLES is the device name listed in this FDA 510(k) record. The listed applicant is Orthion Corp.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K823154. The device is classified under product code IKX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHOWER STOOL W/HANDLES?

SHOWER STOOL W/HANDLES is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Orthion Corp.. The 510(k) number is K823154.

When did SHOWER STOOL W/HANDLES receive FDA 510(k) clearance?

SHOWER STOOL W/HANDLES received FDA 510(k) clearance on 1982-11-05, under 510(k) number K823154.

Who is the listed applicant for SHOWER STOOL W/HANDLES?

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

What is the FDA product code for SHOWER STOOL W/HANDLES?

The FDA product code for SHOWER STOOL W/HANDLES is IKX.

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Other records listing Orthion 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.

K832546MARK V HIGH VOLTAGE GALVANIC STIMULATORRK823151OB TRIPP TRANSPORT CHAIRK823149OB TILT TABLEK823105RESI-WALKERK823155LAVATORY SEAT HEIGHTENERK823153BATH TUB SEAT & BATH BOARD

View all 11 devices →

Related Devices (Code: IKX)

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.

K862895TRICYCLESMednet, Inc.K842650WALL GRAB BARS 98130-98136Guardian Products Co., Inc.K831541TUB TRANSFER BENCH BK6481Fred Sammons, Inc.K823639BOARD TO TRANSFER PARALYZED PATIENT FROMFred Sammons, Inc.K823640BATH TUB SAFETY BARFred Sammons, Inc.K823634CHAIR OR BED LEG EXTENDERSFred Sammons, 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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