PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330— 510(k) K980087

Substantially Equivalent

Pressure Products, Inc.

FDA 510(k) clearance K980087 for PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330, Substantially Equivalent on 1998-07-01. Applicant: Pressure Products, Inc..

Clearance details

Applicant: Pressure Products, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1998-01-09
Decision date: 1998-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Palos Verdes, CA, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.