CS-Pro MED

Primary DI
00860014430503
Brand
CS-Pro MED
Company
CURATIVE SOUND, LLC
Model
CS-Pro MED
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250779000CS-Pro MEDCurative Sound Therapeutics2025-07-02PZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014430503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014430503008600144305038600144305030860014430503

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary extracorporeal shock wave therapy system, hand-heldA hand-held, electrically-powered assembly of devices designed to provide noninvasive extracorporeal shock wave therapy [ESWT] (e.g., spark-gap-generated, piezoelectric) to treat a variety of conditions (e.g., tendinopathy, plantar fasciitis, acute wounds, pelvic pain) across a range of clinical disciplines [e.g., orthopaedics, dermatology, urology]. It consists of a hand-held applicator with an integrated transducer, designed for transcutaneous transmission of acoustic shock waves to the target area. Treatment depth is adjustable via interchangeable standoffs. The applied energy is intended to stimulate the body's natural healing processes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108756583
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260484571267Softwave Gold LiMTS Medical AGPZL2024-08-30
04260484571274Softwave Gold LiMTS Medical AGPZL2024-08-30
04260484571823Dermagold100MTS Medical AGPZL2023-09-11
04260484571830Dermagold100MTS Medical UG (haftungsbeschränkt)PZL2023-09-11
07630039101404DUOLITH®Storz Medical AGPZL2021-06-29
07630039101398DUOLITH®Storz Medical AGPZL2021-04-08
00812265010201dermaPACE ApplicatorSANUWAVE Health, Inc.PZL2021-01-25
00812265010218dermaPACE ConsoleSANUWAVE Health, Inc.PZL2021-01-25
00812265010225dermaPACE System (Console with applicator)SANUWAVE Health, Inc.PZL2021-01-25
04260484571649DermaGold100®MTS Medical AGPZL2020-03-31