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FDA 510(k)

BURNETT-KETCHUM DYNAMIC HAND EXERCISER

K-Number: K790527 · 1979-03-22

ApplicantMaddak, Inc.
Decision Date1979-03-22
Product CodeJFA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BURNETT-KETCHUM DYNAMIC HAND EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1979-03-22 under 510(k) number K790527. The device is classified under product code JFA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURNETT-KETCHUM DYNAMIC HAND EXERCISER?

BURNETT-KETCHUM DYNAMIC HAND EXERCISER is a medical device that received FDA 510(k) clearance on 1979-03-22. The listed applicant is Maddak, Inc.. The 510(k) number is K790527.

When did BURNETT-KETCHUM DYNAMIC HAND EXERCISER receive FDA 510(k) clearance?

BURNETT-KETCHUM DYNAMIC HAND EXERCISER received FDA 510(k) clearance on 1979-03-22, under 510(k) number K790527.

Who is the listed applicant for BURNETT-KETCHUM DYNAMIC HAND EXERCISER?

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 BURNETT-KETCHUM DYNAMIC HAND EXERCISER?

The FDA product code for BURNETT-KETCHUM DYNAMIC HAND EXERCISER is JFA.

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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: JFA)

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.

K945803THERMAFLEX, MODEL SD 55 C.P.M.H.Burke Neutech, Inc.K931016JACE MODEL H440 HAND CPM DEVICEJace Systems, Inc.K933418HAND THERAPY ASSOSTBardon Ent., Inc.K921351JACE MODEL PM-410 HAND CPM DEVICEJace Systems, Inc.K900794MOBILIMB H3 HAND CPM UNITToronto Medical Corp.K900581DANNIFLEX CPM 880(TM)Buckman Co., 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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