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FDA 510(k)

HYDRA-GYM ATHLETICS INC.

K-Number: K841413 · 1984-04-18

ApplicantHydra Fitness Industries
Decision Date1984-04-18
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HYDRA-GYM ATHLETICS INC. is the device name listed in this FDA 510(k) record. The listed applicant is Hydra Fitness Industries. It received FDA 510(k) clearance on 1984-04-18 under 510(k) number K841413. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRA-GYM ATHLETICS INC.?

HYDRA-GYM ATHLETICS INC. is a medical device that received FDA 510(k) clearance on 1984-04-18. The listed applicant is Hydra Fitness Industries. The 510(k) number is K841413.

When did HYDRA-GYM ATHLETICS INC. receive FDA 510(k) clearance?

HYDRA-GYM ATHLETICS INC. received FDA 510(k) clearance on 1984-04-18, under 510(k) number K841413.

Who is the listed applicant for HYDRA-GYM ATHLETICS INC.?

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

What is the FDA product code for HYDRA-GYM ATHLETICS INC.?

The FDA product code for HYDRA-GYM ATHLETICS INC. is BXB.

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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