Skip to content

SoftWave Provider? Click here to learn more about SoftWaveClinics.com


CLEARANCES

CLEARANCES


Lithotriptor, Extracorporeal Shock-Wave, Urological – LithoGold

Proprietary Name: LithoGold
Classification Name: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE, UROLOGICAL
Product Code: LNS
Device Class: 2
Regulation Number: 876.5990
Medical Specialty: Gastroenterology
Registered Establishment Name: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC
Registered Establishment Number: 3006066512
Premarket Submission Number: K062081
Owner/Operator: TISSUE REGENERATION TECHNOLOGIES, LLC
Owner/Operator Number: 9094965
Establishment Operations: Specification Developer; Complaint File Establishment

Click here to read more

Massager, Therapeutic, Electric – DermaGold; OrthoGold; UroGold

Proprietary Name: Applicator OE0035 and OE0050; DermaGold; OrthoGold; UroGold
Classification Name: MASSAGER, THERAPEUTIC, ELECTRIC
Product Code: ISA
Device Class: 1
Regulation Number: 890.5660
Medical Specialty: Physical Medicine
Registered Establishment Name: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC
Registered Establishment Number: 3006066512
Owner/Operator: TISSUE REGENERATION TECHNOLOGIES, LLC
Owner/Operator Number: 9094965
Establishment Operations: Specification Developer; Complaint File Establishment

Click here to read more

Massager, Therapeutic, Electric – DermaGold, OrthoGold

Proprietary Name: DermaGold, OrthoGold
Classification Name: MASSAGER, THERAPEUTIC, ELECTRIC
Product Code: ISA
Device Class: 1
Regulation Number: 890.5660
Medical Specialty: Physical Medicine
Registered Establishment Name: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC
Registered Establishment Number: 3006066512
Premarket Submission Number: K182682
Owner/Operator: TISSUE REGENERATION TECHNOLOGIES, LLC
Owner/Operator Number: 9094965
Establishment Operations: Specification Developer; Complaint File Establishment

Click here to read more

Extracorporeal Shock Wave Device for Treatment of Diabetic Foot Ulcers – DermaGold, OrthoGold

Proprietary Name: DermaGold, OrthoGold
Classification Name: EXTRACORPOREAL SHOCK WAVE DEVICE FOR TREATMENT OF DIABETIC FOOT ULCERS
Product Code: PZL
Device Class: 2
Regulation Number: 878.4685
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC
Registered Establishment Number: 3006066512
Premarket Submission Number: K191961
Owner/Operator: TISSUE REGENERATION TECHNOLOGIES, LLC
Owner/Operator Number: 9094965
Establishment Operations: Specification Developer; Complaint File Establishment

Click here to read more