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Soma Therapy OTC

AUGUSTA MEDICAL SYSTEMS, L.L.C. · Model External Penile Rigidity Device · UDI-DI 00852598007103

LKY
10
510(k) clearances
17
Adverse events
0
Recalls
48
Facilities

Description

Manual Operated device that contains kit bag, manual vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone.

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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.