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FDA 510(k)

FITNESS

K-Number: K833249 · 1983-11-07

ApplicantFitness Equipment Co., Inc.
Decision Date1983-11-07
Product CodeION
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FITNESS is the device name listed in this FDA 510(k) record. The listed applicant is Fitness Equipment Co., Inc.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K833249. 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 FITNESS?

FITNESS is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Fitness Equipment Co., Inc.. The 510(k) number is K833249.

When did FITNESS receive FDA 510(k) clearance?

FITNESS received FDA 510(k) clearance on 1983-11-07, under 510(k) number K833249.

Who is the listed applicant for FITNESS?

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

What is the FDA product code for FITNESS?

The FDA product code for FITNESS is ION.

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

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.K832968PEDAL EXERCISERMaddak, 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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