Compact-II

GUDID 08809308380782

Electromagnetic stimulator

Enraf-Nonius B.V.

Deep-tissue electromagnetic stimulation system, professional
Primary Device ID08809308380782
NIH Device Record Keyd430ca47-a21e-4b37-bdd0-d070d560e16b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompact-II
Version Model Number3442208
Company DUNS414024224
Company NameEnraf-Nonius B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809308380782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-01
Device Publish Date2025-09-23

Devices Manufactured by Enraf-Nonius B.V.

08720618311177 - Curapuls 6702025-10-01 Shortwave diathermy device
08809308380782 - Compact-II2025-10-01Electromagnetic stimulator
08809308380782 - Compact-II2025-10-01 Electromagnetic stimulator
08719992508174 - EN-Dynamic Chest Press2025-02-19 Powered Exercise Equipment
08719992508181 - EN-Dynamic Back Trainer2025-02-19 Powered Exercise Equipment
08719992508198 - EN-Dynamic Pull Down2025-02-19 Powered Exercise Equipment
08719992508204 - EN-Dynamic Abdominal Trainer2025-02-19 Powered Exercise Equipment
08719992508211 - EN-Dynamic Leg Extension2025-02-19 Powered Exercise Equipment
08719992508228 - EN-Dynamic Rowing2025-02-19 Powered Exercise Equipment

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