Cryo Sport 2.0 (AVA 501)— 510(k) K252396
Substantially EquivalentAvanutri Equipamentos DE Saúde
FDA 510(k) clearance K252396 for Cryo Sport 2.0 (AVA 501), Substantially Equivalent on 2026-05-29. Applicant: Avanutri Equipamentos DE Saúde. Device class: 2.
Clearance details
- Applicant
- Avanutri Equipamentos DE Saúde
- 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
- Tres Rios, BR
Recent devices under product code IRP
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- K253919 — Cryo And Thermo Therapy System
- K254200 — Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
Data sourced from openFDA. This site is unofficial and independent of the FDA.