FDA.reportPublic FDA data

Sonopuls 494

Primary DI
08720618311139
Brand
Sonopuls 494
Company
Enraf-Nonius B.V.
Model
1498941
Device description
Multi-modality (electrical stimulation/ultrasound/low level laser) physical therapy system
Published
2025-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
ILYLamp, Infrared, Therapeutic Heating
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153559000OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)2016-08-26IMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720618311139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720618311139087206183111398720618311139

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy systemAn assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy, plantar fasciitis); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

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
08720618311177Curapuls 67016709312025-09-23
08809308380782Compact-II34422082025-09-23
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

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