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kinderBAND

BIOSCULPTOR CORPORATION · Model CL-4000 · UDI-DI 00863457000302

MVA OAN Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.

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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.