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
- 510(k)K252849Substantially equivalent (SESE) · 2026-04-30clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-11-06 | NAI | No action indicated | Tactile Systems Technology, Inc. | 0 |
| 2017-11-06 | NAI | No action indicated | Tactile Systems Technology, Inc. | 0 |
| 2013-10-29 | NAI | No action indicated | Tactile Systems Technology, Inc. | 0 |
| 2013-10-29 | NAI | No action indicated | Tactile Systems Technology, Inc. | 0 |
| 2010-07-20 | NAI | No action indicated | Tactile Systems Technology, Inc. | 0 |
| 2010-07-20 | NAI | No action indicated | Tactile Systems Technology, Inc. | 0 |
Similar devices
- AffloVest Movair, Inc.
- AffloVest Movair, Inc.
- AffloVest Movair, Inc.
- AffloVest Movair, Inc.
- AffloVest Movair, Inc.
- AffloVest Movair, Inc.
- AffloVest Movair, Inc.
- AirPhysio AIRPHYSIO PTY. LTD.
- BALLARD™ SUNMED, LLC
- Ballard* Manual Percussor Avanos Medical, Inc.
- ClearChest® Respiratory Technologies, Inc.
- ClearChest® Respiratory Technologies, Inc.
Select up to two to place side-by-side with this device.