FDA.reportPublic FDA data

SWISS DOLORCLAST

Primary DI
07613353226053
Brand
SWISS DOLORCLAST
Company
E.M.S. Electro Medical Systems S.A.
Model
A
Catalog number
FT-250#A/002
Device description
DolorClast Radial
Published
2022-09-13
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220538000DolorClast RadialE.M.S Electro Medical Systems S.A2022-07-11ISA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353226053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353226053076133532260537613353226053

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
481233849
Device count
1
Serial number
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

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