Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-07-11 | NAI | No action indicated | Adroit Medical Systems Inc | 0 |
| 2025-07-11 | NAI | No action indicated | Adroit Medical Systems Inc | 0 |
| 2019-04-11 | VAI | Voluntary action indicated | Adroit Medical Systems Inc | 4 |
| 2019-04-11 | VAI | Voluntary action indicated | Adroit Medical Systems Inc | 4 |
| 2017-07-12 | VAI | Voluntary action indicated | Adroit Medical Systems Inc | 2 |
| 2017-07-12 | VAI | Voluntary action indicated | Adroit Medical Systems Inc | 2 |
| 2012-01-23 | VAI | Voluntary action indicated | Adroit Medical Systems Inc | 2 |
| 2012-01-23 | VAI | Voluntary action indicated | Adroit Medical Systems Inc | 2 |
| 2010-01-28 | NAI | No action indicated | Adroit Medical Systems Inc | 0 |
| 2010-01-28 | NAI | No action indicated | Adroit Medical Systems Inc | 0 |
Similar devices
- "ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13""" THERMOTEK, INC.
- "ThermoTek WRAP, KNEE, ROM BRACE, L, 13""" THERMOTEK, INC.
- "ThermoTek WRAP, KNEE, ROM BRACE, M, 13""" THERMOTEK, INC.
- "ThermoTek WRAP, KNEE, ROM BRACE, XL, 13""" THERMOTEK, INC.
- "ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13""" THERMOTEK, INC.
- / Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
- / Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
- AIRCAST DJO, LLC
- AIRCAST DJO, LLC
- AIRCAST DJO, LLC
- AIRCAST DJO, LLC
- AIRCAST DJO, LLC
Select up to two to place side-by-side with this device.