FDA 510(k)

COMFORTEX WHEELCHAIR CUSHION

K-Number: K855181 · 1986-01-13

Decision Date1986-01-13

Product CodeKNN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

COMFORTEX WHEELCHAIR CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Comfortex, Inc.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K855181. 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 COMFORTEX WHEELCHAIR CUSHION?

COMFORTEX WHEELCHAIR CUSHION is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Comfortex, Inc.. The 510(k) number is K855181.

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

COMFORTEX WHEELCHAIR CUSHION received FDA 510(k) clearance on 1986-01-13, under 510(k) number K855181.

Who is the listed applicant for COMFORTEX WHEELCHAIR CUSHION?

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

What is the FDA product code for COMFORTEX WHEELCHAIR CUSHION?

The FDA product code for COMFORTEX WHEELCHAIR CUSHION 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Comfortex, Inc. as applicant

K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICE K855179TRANSFER-TRAX (TM) SPLINT TRACTION K854270MURPHY ADJUSTABLE SPLINT

Related Devices (Code: KNN)

K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC K942309DYNASTY U1-31 (GELL/CELL)Foley & Lardner K942311DYNASTY U1-33 AGMFoley & Lardner K942308DYNASTY GC 12400 (GELL/CELL)Foley & Lardner K942310DYNASTY GC 12550 (GELL/CELL)Foley & Lardner K942312ALDEN 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.