Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC

K-Number: K923186 · 1992-09-09

ApplicantRoho, Inc.
Decision Date1992-09-09
Product CodeKNN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC is the device name listed in this FDA 510(k) record. The listed applicant is Roho, Inc.. It received FDA 510(k) clearance on 1992-09-09 under 510(k) number K923186. 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 NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC?

NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC is a medical device that received FDA 510(k) clearance on 1992-09-09. The listed applicant is Roho, Inc.. The 510(k) number is K923186.

When did NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC receive FDA 510(k) clearance?

NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC received FDA 510(k) clearance on 1992-09-09, under 510(k) number K923186.

Who is the listed applicant for NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC?

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

What is the FDA product code for NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC?

The FDA product code for NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC 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 Roho, 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.

K861327ROHO HEEL PAD

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑