FDA-Device2016-12-14Class II

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

DeRoyal Industries Inc
Hazard

DeRoyal received complaints of mold on Tennis Elbow Straps.

Sold states
US Nationwide Distribution
Affected count
56 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2017

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