IMJClass II

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Physical Medicine · 21 CFR 890.5290

MDR events25All time

Recalls1All time

Registered firms16Currently listed

510(k) clearances45All time

Recent MDR events

25 adverse event reports on file

Event type breakdown

Injury17

Malfunction8

Most-reported manufacturers

Btl Industries Limited6 Djo, Llc4 Dj Orthopedics De Mexico, S.a. De C.v.2 International Medical Electronics, Ltd.2 Mettler Electronics Corp.2 Acp Accelerated Care Plus1 Chattanooga Group1 Dj Orthopedics De Mexico1

Recalls

1 recall events for this product code

DJO, LLC
TerminatedOct 15, 2015
Monode, Shortwave Accessory
Overheating and burning of the wire insulation inside the applicator.
Z-0121-2016 · View FDA record ↗

Registered firms

16 firms currently registered for this product code

510(k) clearances

45 clearances for this product code