JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031— 510(k) K982761

Name: FDA 510(k) clearance K982761
Creator: U.S. Food and Drug Administration
Published: 1998-10-22

Substantially Equivalent

Chamco, Inc.

FDA 510(k) clearance K982761 for JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031, Substantially Equivalent on 1998-10-22. Applicant: Chamco, Inc.. Device class: 2.

Clearance details

Applicant: Chamco, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1998-08-06
Decision date: 1998-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cocoa, FL, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.