BEMER Classic Set, BEMER Pro-Set— 510(k) K151834

Substantially Equivalent

Bemer Int AG

FDA 510(k) clearance K151834 for BEMER Classic Set, BEMER Pro-Set, Substantially Equivalent on 2017-02-22. Applicant: Bemer Int AG. Device class: 2.

Clearance details

Applicant: Bemer Int AG
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2015-07-06
Decision date: 2017-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Triesen, LI

Download summary PDF View on FDA.gov ↗

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More clearances from Bemer Int AG

K223919 — B.Light Clear Evo and B.Light Restore Evo2023-09-23
K231368 — Bemer Therapy System Evo2023-06-09
K210174 — BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set2021-02-04

Recalls naming K151834

K-number listed on FDA's recall record

Z-1105-2021 — Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)Class II·Terminated·BEMER INT. AG·20210113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151834.

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