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FDA 510(k)

SWIVEL HEAD ADJUSTABLE CRUTCH

K-Number: K770146 · 1977-01-28

ApplicantMaddak, Inc.
Decision Date1977-01-28
Product CodeIPR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SWIVEL HEAD ADJUSTABLE CRUTCH is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1977-01-28 under 510(k) number K770146. The device is classified under product code IPR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWIVEL HEAD ADJUSTABLE CRUTCH?

SWIVEL HEAD ADJUSTABLE CRUTCH is a medical device that received FDA 510(k) clearance on 1977-01-28. The listed applicant is Maddak, Inc.. The 510(k) number is K770146.

When did SWIVEL HEAD ADJUSTABLE CRUTCH receive FDA 510(k) clearance?

SWIVEL HEAD ADJUSTABLE CRUTCH received FDA 510(k) clearance on 1977-01-28, under 510(k) number K770146.

Who is the listed applicant for SWIVEL HEAD ADJUSTABLE CRUTCH?

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 SWIVEL HEAD ADJUSTABLE CRUTCH?

The FDA product code for SWIVEL HEAD ADJUSTABLE CRUTCH is IPR.

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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: IPR)

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.

K821403LIGHT WEIGHT ALUMINUM CRUTCHESManuco Manufacturing Co., Inc.K800237FOLDING CRUTCHHusa Folding Crutch Co., Inc.K790557CRUTCHMaddak, 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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