ManaCold Compression System
Summary
Manamed, LLC received 510(k) clearance for ManaCold Compression System, a IRP device. Cleared on 2026-08-12.
Details
Source
510(k) Clearance
External ID
K260944
Action Date
2026-08-12
Status
Traditional
Category
device
Product Code
IRP
Product Description
ManaCold Compression System. Product code: IRP.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 376 device clearances issued this month. Manamed, LLC has received 2 total clearances in our database.
Manamed, LLC has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Manamed, LLC have FDA actions?
Manamed, LLC has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260944" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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