FDA.reportPublic FDA data

Compact-II

Primary DI
08809308380782
Brand
Compact-II
Company
Enraf-Nonius B.V.
Model
3442208
Device description
Electromagnetic stimulator
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251083000Compact IIEnraf-Nonius, B.V.2025-09-12IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809308380782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809308380782088093083807828809308380782

GMDN Terms#

Term, Definition table
TermDefinition
Deep-tissue electromagnetic stimulation system, professionalAn assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); 3) help facilitate soft and hard tissue wound/injury healing; and/or 4) reduce subcutaneous fat layers by muscle stimulation. It includes an electrically-powered control unit and application pads/flat coils intended to emit EM radiation to the treatment site. It is not intended to apply an electric current directly to the body nor produce therapeutic deep heat. The system is intended to be used in a clinical setting only.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414024224
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720618311139Sonopuls 49414989412025-02-11
08720618311177Curapuls 67016709312025-09-23
08719992508174EN-Dynamic Chest Press14559512025-02-11
08719992508181EN-Dynamic Back Trainer14559522025-02-11
08719992508198EN-Dynamic Pull Down14559532025-02-11
08719992508204EN-Dynamic Abdominal Trainer14559542025-02-11
08719992508211EN-Dynamic Leg Extension14559552025-02-11
08719992508228EN-Dynamic Rowing14559562025-02-11
08719992508235EN-Dynamic Shoulder Press14559572025-02-11
08719992508242EN-Dynamic Adduction14559582025-02-11
08719992508259EN-Dynamic Abduction14559592025-02-11
08719992508266EN-Dynamic Fly14559602025-02-11
08719992508273EN-Dynamic Total Hip14559612025-02-11
08719992508280EN-Dynamic Seated Leg Curl14559622025-02-11
08719992508297EN-Dynamic Seated Leg Press14559632025-02-11
08719992508303EN-Dynamic Triceps Dips14559642025-02-11
08719992508310EN-Dynamic Squat14559652025-02-11
08719992508327EN-Dynamic Rotator14559662025-02-11
08720618311108Sonopuls 19016319512025-02-11
08720618311153Endolaser 12016339312025-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.IPF2026-06-04
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17