FDA.reportPublic FDA data

Orthospec

Primary DI
07290016498417
Brand
Orthospec
Company
MEDISPEC LTD.
Model
OR-3-A999u
Device description
Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciitis and who have failed previous conservative therapies.
Published
2017-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P040026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040026000ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICEMedispec, Ltd.2005-04-01NBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016498417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016498417072900164984177290016498417

GMDN Terms#

Term, Definition table
TermDefinition
Spark-gap orthopaedic extracorporeal shock wave therapy systemA mobile assembly of devices designed to provide spark-gap-generated orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a generator with two submerged electrodes that produce spark-gap (electrohydraulic) energy, at selected impulse frequencies, transmitted in reflector-focused waves to a target area on the patient's body surface via a water-filled membrane (e.g., latex) held against the target area during treatment. It is used to treat disorders such as patellar tendonitis, soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), and/or non-union fractures of bones.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600300909
Device count
1
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016498615SlimspecLX-5-A999b2023-06-07
07290016498455LithospecLS-6-A999b2023-06-08
07290016498110Omnispec ED1000OR-5-A999k2023-06-07
07290016498752RadialspecLS-5-A999b2023-06-07
07290016498257Econolith E2000SW-7-A9992018-08-08
07290016498301Econolith E3000SW-6-A999b2018-08-08
07290016498318Econolith E3000SW-6-A999d2018-08-08
07290016498356Econolith EM1000SW-8A999b2018-08-08
07290016498363Econolith EM1000SW-8-A999d2018-08-08
07290016498370Econolith EM1000SW-8-A999m2018-08-08
07290016498387Econolith EM1000SW-8-A999q2018-08-08
07290016498394Econolith EM1000SW-8-A999r2018-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630039101404DUOLITH®Storz Medical AGNBN2021-06-29
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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
07613353181284Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2019-10-16
07613353077464Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2018-06-22
07630039101022CHATTANOOGAStorz Medical AGNBN2018-05-28
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