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
