Softwave Gold Li

Basic Information

• Brand Name: Softwave Gold Li
• Primary DI: 04260484571267
• Version / Model: OW100S-US
• Catalog Number: 1000024
• Company Name: MTS Medical AG
• Labeler DUNS: 342585299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: b7b9fea0-21ce-4ea2-8735-e194ae9d4a6d

Device Description

The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	878.4685	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59043	Dermatological extracorporeal shock wave therapy system	An assembly of devices designed to provide spark-gap-generated extracorporeal shock wave therapy (ESWT) intended to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds; cellulite). It typically consists of a generator that supplies the high voltage energy; and a hand-held, fluid-filled, shock wave applicator that produces spark-gap (electrohydraulic) energy delivered non-invasively to the area of the skin in contact with the applicator. Treatment parameters are intended to be input manually or from a pre-programmed radio-frequency identification (RFID) card.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260484571274	GS1	Box	1	In Commercial Distribution
Primary	04260484571267	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233937	000

Device Sizes

Type	Value	Unit	Text
Weight	21	Kilogram
Depth	459	Millimeter
Width	400	Millimeter
Height	218	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 82 – 106 KiloPascal