SACS PRO— 510(k) K243177

Substantially Equivalent

Elastimed , Ltd.

FDA 510(k) clearance K243177 for SACS PRO, Substantially Equivalent on 2024-12-23. Applicant: Elastimed , Ltd.. Device class: 2.

Clearance details

Applicant: Elastimed , Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2024-09-30
Decision date: 2024-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokne'Am Illit, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRP

K260944 — ManaCold Compression System2026-08-12
K260529 — Air Compression Massager (HY-1165)2026-07-27
K260948 — Air Compression Massager (EP30B001 I)2026-07-24
K253919 — Cryo And Thermo Therapy System2026-06-10
K252396 — Cryo Sport 2.0 (AVA 501)2026-05-29

More clearances from Elastimed , Ltd.

K232300 — ElastiMed SACS2023-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.