FDA.reportPublic FDA data

Swiss DolorClast

Primary DI
07613353181284
Brand
Swiss DolorClast
Company
E.M.S. Electro Medical Systems S.A.
Model
EL-341
Device description
Handpiece DolorClast
Published
2019-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBNGenerator, Shock-Wave, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBNGenerator, Shock-Wave, For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050004001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050004001EMS SWISS DOLORCLASTElectro Medical Systems (Ems Sa)2007-05-08NBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353181284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353181284076133531812847613353181284

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic orthopaedic extracorporeal shock wave therapy systemAn assembly of devices designed to provide pneumatic orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a control unit that produces pneumatically-generated shock waves at selected impulse frequencies, and a hand-held surface applicator used to apply the energy to the site of pain. It is commonly used to treat disorders such as tendinopathies (e.g., rotator cuff, patellar, Achilles), soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), shin splints, and muscle-related pain syndromes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41229944700welcome@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353313500GBT Machine StationDW-1002026-02-16
04262477320197SONOGELDV-1552025-09-02
04260153472031Swiss DolorClastDV-0332021-06-02
07613353170264Swiss DolorClastDV-0332020-06-03
07613353352356GBT Machine AIRFLOW Prophylaxis MasterFT-300#NFSFT-300 -01-202026-02-24
07613353180089Instruments A P PSFS-4582026-02-16
07613353180096Instruments PS PSR PSLFS-4592026-02-16
07613353225940GBT FLOWCONTROL x 4FV-112/A2026-02-16
07613353331184GBT Machine Wireless PedalEK-1055B2026-02-16
07613353334925AIR-FLOWFS-465FS-465/MX2026-02-16
07613353335847AIR-FLOWFS-477/US2026-02-16
07613353336837Instruments PSR PSLFS-4612026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2B 3022026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2BV022026-02-16
07613353348137AIR-FLOWFS-474FS-474/MX2026-02-16
07613353335113PIEZONFS-4552025-10-21
07613353341404PiezonEN-060#MX2025-10-21
07613353257224AIR-FLOW-PIEZONFT-229Default2025-10-20
07613353257323AIR-FLOW-PIEZONFT-229-2B-V022025-10-20
07613353257576AIR-FLOW-PIEZONFT-229-2B-3022025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630039101404DUOLITH®Storz Medical AGNBN2021-06-29
04260153472031Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2021-06-02
07630039101398DUOLITH®Storz Medical AGNBN2021-04-08
07613353194895SWISS DOLORCLASTE.M.S. Electro Medical Systems S.A.NBN2020-08-25
07613353170264Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2020-06-03
07630039101312CHATTANOOGAStorz Medical AGNBN2020-03-23
07630039101329DUOLITH®Storz Medical AGNBN2020-03-23
07630039101336DUOLITH®Storz Medical AGNBN2020-03-23
07613353077464Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2018-06-22
07630039101022CHATTANOOGAStorz Medical AGNBN2018-05-28
07290016498417OrthospecMEDISPEC LTD.NBN2017-06-22
07630039100827CHATTANOOGAStorz Medical AGNBN2017-01-16
07630039100759CHATTANOOGAStorz Medical AGNBN2016-06-27
07630039100773DUOLITH®Storz Medical AGNBN2016-06-27
07613353000011Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000028Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000042Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000059Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000066Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000035Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-10-26