FDA.reportPublic FDA data

MASTERPULS®

Primary DI
07630039101169
Brand
MASTERPULS®
Company
Storz Medical AG
Model
ONE
Device description
The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator.
Published
2019-09-16
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173692000D-Actor 200 Vibration Massage SystemStorz Medical AG2018-04-13ISA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630039101169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630039101169076300391011697630039101169

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-wave skin contouring systemAn assembly of devices using extracorporeal pulse activation technology (EPAT) and designed for acoustic wave treatment (AWT) intended primarily to reduce the appearance of cellulite through mobilization of free fatty acids and oxidative agents in tissue. It typically consists of a control unit that produces pneumatically-generated and/or electrically-generated pressure waves at selected impulse frequencies by means of one or more hand-held, skin-surface applicators. The system may also be used to treat the skin, e.g., by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used to treat minor muscle pain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481967776
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630039101855MASTERPULS®icon37000.00022026-04-15
07630039101909MASTERPULS®R-SW10043000.00022026-03-01
07630039100919MODULITH®SLX-F2290002021-04-13
07630039101817MASTERPULS®MP10023232.01042024-10-01
07630039101343DUOLITH®SD1 R-SW19880.00062021-06-01
07630039101039D-ACTOR®2002018-05-28
07630039101060D-ACTOR®1002018-10-28
07630039101121D-ACTOR®502018-11-15
07630039101442MODULITH®SLX-F239000.00012025-04-11
07630039101459MODULITH®SLX-F239000.00022025-04-11
07630039101466MODULITH®SLX-F239000.00032025-04-11
07630039100803StorM-Base 2.032016-09-23
07630039100773DUOLITH®SD1 T-Top2016-06-27
07630039101336DUOLITH®SD1 Tower2020-03-23
07630039100230MODULITH®SLX-F22016-08-24
07630039101398DUOLITH®SD1 T-Top21362.01022021-04-08
07630039101404DUOLITH®SD1 Tower19880.00052021-06-29
07630039101350MAGNETOLITH31500.00022021-06-01
07630039101329DUOLITH®SD1 T-Top2020-03-23
07630039101046XR-MX/1000FD43 (80 kW)292552021-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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