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FDA 510(k)

THERA-FIT

K-Number: K930821 · 1994-11-09

ApplicantAquatherapy Systems, Inc.
Decision Date1994-11-09
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERA-FIT is the device name listed in this FDA 510(k) record. The listed applicant is Aquatherapy Systems, Inc.. It received FDA 510(k) clearance on 1994-11-09 under 510(k) number K930821. 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 THERA-FIT?

THERA-FIT is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is Aquatherapy Systems, Inc.. The 510(k) number is K930821.

When did THERA-FIT receive FDA 510(k) clearance?

THERA-FIT received FDA 510(k) clearance on 1994-11-09, under 510(k) number K930821.

Who is the listed applicant for THERA-FIT?

The FDA 510(k) record lists Aquatherapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERA-FIT?

The FDA product code for THERA-FIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aquatherapy Systems, 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.

K930820AQUADYNE

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.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.

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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