PAIN CARE 3000— 510(k) K002073

Name: FDA 510(k) clearance K002073
Creator: U.S. Food and Drug Administration
Published: 2000-09-19

Substantially Equivalent

Breg, Inc.

FDA 510(k) clearance K002073 for PAIN CARE 3000, Substantially Equivalent on 2000-09-19. Applicant: Breg, Inc.. Device class: 2.

Clearance details

Applicant: Breg, Inc.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2000-07-10
Decision date: 2000-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Breg, Inc.

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K183702 — Polar Care Wave2019-03-01
K070402 — MODIFICATION TO POLAR CARE 5002007-03-29
K041714 — E-PAIN CARE2004-10-01
K020988 — PAIN CARE 42002002-04-04
K013928 — PAIN CARE 32002001-12-03

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.