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