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FDA 510(k)

SHS CUSHION/WHEELCHAIR

K-Number: K861755 · 1986-05-23

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

Device Summary

SHS CUSHION/WHEELCHAIR 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 K861755. 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 SHS CUSHION/WHEELCHAIR?

SHS CUSHION/WHEELCHAIR 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 K861755.

When did SHS CUSHION/WHEELCHAIR receive FDA 510(k) clearance?

SHS CUSHION/WHEELCHAIR received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861755.

Who is the listed applicant for SHS CUSHION/WHEELCHAIR?

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 SHS CUSHION/WHEELCHAIR?

The FDA product code for SHS CUSHION/WHEELCHAIR 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.

K861751THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYSK861754KINESETHETIC 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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