Atlas FDA

LBG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Device, Fluidized Therapy, Dry Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5500
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 2 · 1999: 1 · 2000: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDateBuilder
ELECTRONIC CELL ENERGIZER (K834293)Electronic Energy, Inc.1984-01-13+ Add

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