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FDA 510(k)

THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS

K-Number: K861751 · 1986-05-23

ApplicantSpecial Health Systems, Ltd.
Decision Date1986-05-23
Product CodeKNN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS is the device name listed in this FDA 510(k) record. The listed applicant is Special Health Systems, Ltd.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861751. The device is classified under product code KNN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS?

THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Special Health Systems, Ltd.. The 510(k) number is K861751.

When did THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS receive FDA 510(k) clearance?

THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861751.

Who is the listed applicant for THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS?

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

What is the FDA product code for THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS?

The FDA product code for THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS is KNN.

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 Special Health Systems, Ltd. 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.

K861755SHS CUSHION/WHEELCHAIRK861754KINESETHETIC SEATING SYSTEM/WHEELCHAIR

Related Devices (Code: KNN)

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.

K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLCK942309DYNASTY U1-31 (GELL/CELL)Foley & LardnerK942311DYNASTY U1-33 AGMFoley & LardnerK942308DYNASTY GC 12400 (GELL/CELL)Foley & LardnerK942310DYNASTY GC 12550 (GELL/CELL)Foley & LardnerK942312ALDEN LINEAGE WHEELCHAIR CUSHIONLewis W. Ward

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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