FDA Device Intelligence
HomeUNIBELL SRL › SUPERCHARGE HYDRA FASCIA ELECTRODES

SUPERCHARGE HYDRA FASCIA ELECTRODES

UNIBELL SRL · Model 16568 · UDI-DI 08056182721327

PBX Prescription
1
510(k) clearances
63
Adverse events
1
Recalls
73
Facilities

Description

Non-sterile commercial kit containing eight stimulation electrodes packaged together for convenience. The electrodes included in the kit are identical to devices marketed individually and are capacitive electrodes specific for the HCR1002 medical device: Structuranova / Ø 25 mm | sphere Structuranova / Ø 65 mm | thickness 25 mm Structuranova / Ø 90 mm | hickness 25 mm Lymphanova / oval Ømaj 20mm thickness 14mm Lymphanova / oval Ømaj 40mm thickness 14 mm Lymphanova / oval Ømaj 60mm thickness 14 mm Lymphanova / Ø 90 mm | ball Lymphanova / Ø 105 mm tickness 14 mm

Recalls

DateFirmReason
2017-07-13Bios S.r.l.In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.