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FDA 510(k)

HYDROTONE I

K-Number: K890308 · 1989-01-31

ApplicantHydrotonics Therapy Corp.
Decision Date1989-01-31
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HYDROTONE I is the device name listed in this FDA 510(k) record. The listed applicant is Hydrotonics Therapy Corp.. It received FDA 510(k) clearance on 1989-01-31 under 510(k) number K890308. The device is classified under product code ILJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROTONE I?

HYDROTONE I is a medical device that received FDA 510(k) clearance on 1989-01-31. The listed applicant is Hydrotonics Therapy Corp.. The 510(k) number is K890308.

When did HYDROTONE I receive FDA 510(k) clearance?

HYDROTONE I received FDA 510(k) clearance on 1989-01-31, under 510(k) number K890308.

Who is the listed applicant for HYDROTONE I?

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

What is the FDA product code for HYDROTONE I?

The FDA product code for HYDROTONE I is ILJ.

Related Clinical Trials

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.

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Related Devices (Code: ILJ)

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.

K110994PARKER 500Arjohuntleigh, Inc.K082951IMMERSION HYDROBATHArjo Hospital Equipment ABK052479MBATH 1000 (60)Enneking Medical, Inc.K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, 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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