KOLD WRAP— 510(k) K801365

Substantially Equivalent

Romaine, Inc.

FDA 510(k) clearance K801365 for KOLD WRAP, Substantially Equivalent on 1980-08-07. Applicant: Romaine, Inc..

Clearance details

Applicant: Romaine, Inc.
Product code: Code IME
Advisory panel: Physical Medicine
Date received: 1980-06-10
Decision date: 1980-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code IME

product code IME

Other: 1
Total: 1

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.