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FDA 510(k)

RHEUMATOID HAND GYM

K-Number: K770144 · 1977-01-28

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

Device Summary

RHEUMATOID HAND GYM 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 K770144. The device is classified under product code ION. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHEUMATOID HAND GYM?

RHEUMATOID HAND GYM 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 K770144.

When did RHEUMATOID HAND GYM receive FDA 510(k) clearance?

RHEUMATOID HAND GYM received FDA 510(k) clearance on 1977-01-28, under 510(k) number K770144.

Who is the listed applicant for RHEUMATOID HAND GYM?

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 RHEUMATOID HAND GYM?

The FDA product code for RHEUMATOID HAND GYM is ION.

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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: ION)

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.

K120783ABLE-XIm-Able, Ltd.K885343STANDEXAlt, Inc.K851065GRAVITY KING (DEEMED SE 87/09/18)Unique Functional ProductsK840551MOBILIZERLossing Orthopedic, Inc.K833870KNEE WALKERMaddak, Inc.K833249FITNESSFitness Equipment 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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