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SHAPER No.2

Timpel S/A · Model ACE-00035 · UDI-DI 07898966433306

QEB Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
4
Facilities

Description

The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.