Available Use 'Generator Prodigy - W' - FDA? Fitness? Dentist? Annual

Oct 23, 2026

Annual device information for the “Generator Prodigy” system, covering prescription and safety obligations for physicians. States that the system should be sold or used only in accordance with regulations and describes a physician-only indication for use. Provides a structured safety information section including warnings, precautions, contraindications, and potential adverse events. References patient eligibility and emphasizes the need to consult additional clinician materials for proper operation, handling, and compliance requirements.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages140

Reading Time5 h 53 min

AccessFree to download

Prescription and Safety Information

Intended Use

Indications for Use

Contraindications

Adverse Events

Additional Prescription Information

DM/ Safety Information

Warnings and Precautions

/ŵƉůĂŶƚĂďůĞ WƵůƐĞ 'ĞŶĞƌĂƚŽƌ WƌŽĚŝŐǇΡ /W' WƌŽĚŝŐǇ DZ/Ρ /W' 􀀒ůŝŶŝĐŝĂŶΖƐ DĂŶƵĂů 􀀒􀀄hd/KE͗ &ĞĚĞƌĂů ;h^􀀄Ϳ ůĂǁ ƌĞƐƚƌŝĐƚƐ ƚŚŝƐ ĚĞǀŝĐĞ ƚŽ ƐĂůĞ ďǇ Žƌ ŽŶ ƚŚĞ ŽƌĚĞƌ ŽĨ Ă ƉŚǇƐŝĐŝĂŶ͘Ρ /ŶĚŝĐĂƚĞƐ Ă ƚƌĂĚĞŵĂƌŬ ŽĨ ƚŚĞ 􀀄ďďŽƩ ŐƌŽƵƉ ŽĨ ĐŽŵƉĂŶŝĞƐ͘ ΐ /ŶĚŝĐĂƚĞƐ Ă ƚŚŝƌĚͲƉĂƌƚǇ ƚƌĂĚĞŵĂƌŬ͕ ǁŚŝĐŚ ŝƐ ƉƌŽƉĞƌƚǇ ŽĨ ŝƚƐ ƌĞƐƉĞĐƟǀĞ ŽǁŶĞƌ͘ WĂƚ͘ ŚƩƉ͗ͬͬǁǁǁ͘ĂďďŽƩ͘ĐŽŵͬƉĂƚĞŶƚƐ Ξ ϮϬϮϯ 􀀄ďďŽƩ͘ 􀀄ůů ZŝŐŚƚƐ ZĞƐĞƌǀĞĚ͘ 􀀒ŽŶƚĞŶƚƐ WƌĞƐĐƌŝƉƟŽŶ ĂŶĚ ^ĂĨĞƚǇ /ŶĨŽƌŵĂƟŽŶ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭ/ŶƚĞŶĚĞĚ hƐĞ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭ/ŶĚŝĐĂƟŽŶƐ ĨŽƌ hƐĞ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭ􀀒ŽŶƚƌĂŝŶĚŝĐĂƟŽŶƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭ DZ/ ^ĂĨĞƚǇ /ŶĨŽƌŵĂƟŽŶ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭ tĂƌŶŝŶŐƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭ WƌĞĐĂƵƟŽŶƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ Ϯ􀀄ĚǀĞƌƐĞ 􀀜īĞĐƚƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϯ WƌŽĚƵĐƚ 􀀘ĞƐĐƌŝƉƟŽŶ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϰ WĂĐŬĂŐĞ 􀀒ŽŶƚĞŶƚƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϰ/ĚĞŶƟĨǇŝŶŐ ƚŚĞ /W'͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϰ􀀘ŝƌĞĐƟŽŶƐ ĨŽƌ hƐĞ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϱ 􀀒ƌĞĂƟŶŐ ĂŶ /W' WŽĐŬĞƚ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϱ dƵŶŶĞůŝŶŐ ƚŽ ƚŚĞ WŽĐŬĞƚ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϱ􀀒ŽŶŶĞĐƟŶŐ Ă >ĞĂĚ Žƌ 􀀜ǆƚĞŶƐŝŽŶ ƚŽ ƚŚĞ /W'͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϲ/ŵƉůĂŶƟŶŐ ƚŚĞ /W'͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϴ ZĞƉůĂĐŝŶŐ ƚŚĞ /W'͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϵ􀀘ŝƐƉŽƐŝŶŐ ŽĨ 􀀜ǆƉůĂŶƚĞĚ 􀀒ŽŵƉŽŶĞŶƚƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϵ DĂŝŶƚĂŝŶŝŶŐ ƚŚĞ /W' 􀀑ĂƩĞƌǇ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϵ ZĞĐŚĂƌŐŝŶŐ ƚŚĞ /W' 􀀑ĂƩĞƌǇ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭϬ WƌĞƐĞƌǀŝŶŐ ƚŚĞ /W' tŚĞŶ EŽƚ ŝŶ hƐĞ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭϬ dĞĐŚŶŝĐĂů ^ƵƉƉŽƌƚ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭϬ􀀄ƉƉĞŶĚŝǆ 􀀄͗ WƌŽĚƵĐƚ ^ƉĞĐŝĮĐĂƟŽŶƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ϭϬ/W' ^ƉĞĐŝĮĐĂƟŽŶƐ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘ ͘

FAQs

What is the intended use of the Generator Prodigy system?

The document describes the system as intended for use by qualified physicians within an approved medical purpose. It emphasizes restricted distribution and physician-directed use.

Who is indicated to use or manage the system for patients?

Use and management are intended for physicians and appropriate clinical management of chronic conditions or patient needs described in the indication section.

What safety risks and adverse events are mentioned?

The safety section lists potential adverse outcomes related to implant behavior and patient symptoms, and it also instructs readers to consult additional materials for detailed warnings, precautions, and adverse events.

Oct 23, 2026

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