THERACUSHION MODEL 1000— 510(k) K861834

Substantially Equivalent

General Physiotherapy, Inc.

FDA 510(k) clearance K861834 for THERACUSHION MODEL 1000, Substantially Equivalent on 1986-05-27. Applicant: General Physiotherapy, Inc..

Clearance details

Applicant: General Physiotherapy, Inc.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1986-05-13
Decision date: 1986-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

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.