ManaCold Compression System— 510(k) K260944
Substantially EquivalentManamed, LLC
FDA 510(k) clearance K260944 for ManaCold Compression System, Substantially Equivalent on 2026-08-12. Applicant: Manamed, LLC. Device class: 2.
Clearance details
- Applicant
- Manamed, LLC
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denton, TX, US
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More clearances from Manamed, LLC
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