REHASTIM 2, ERIGOPRO (FES)— 510(k) K132416

Substantially Equivalent

Hasomed GmbH

FDA 510(k) clearance K132416 for REHASTIM 2, ERIGOPRO (FES), Substantially Equivalent on 2014-05-28. Applicant: Hasomed GmbH. Device class: 2.

Clearance details

Applicant: Hasomed GmbH
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2013-08-02
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Magdeburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZI

K242704 — Synchrony (20-3000)2025-06-05
K243828 — CIONIC NEURAL SLEEVE (NS-200)2025-05-02
K240632 — Neuvotion NeuStim NN-012024-11-22
K233006 — MyndMove, MyndMove 2.02024-06-25
K230997 — EvoWalk 1.0 System2023-12-28

More clearances from Hasomed GmbH

K162683 — RehaStim 22017-02-03
K112844 — REHASTIM 2, REHAMOVE 22011-10-27
K073237 — REHASTIM & REHAMOVE2007-12-27

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