trtllc.comChiroGold - The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circulation - Activation of connective tissue.
2025-06-30
MTS Medical AG
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005462245 | 3005462245 | MTS Medical AG | 1 | N | 2026-01-01 | ROBERT-BOSCH-STRASSE 18 ROBERT-BOSCH-STRASSE 9 (Production Facility), RO KONSTANZ Baden-Wurttemberg DE 78467 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04260484571267 | Softwave Gold Li - 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) | (888) 862-6162 | info@trtllc.com |
| 04260484571274 | Softwave Gold Li - 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) | (888) 862-6162 | info@trtllc.com |
| 04260484571281 | ChiroGold - The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circulation - Activation of connective tissue. | (888) 862-6162 | info@trtllc.com |
| 04260484571298 | ChiroGold - The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circulation - Activation of connective tissue. | (888) 862-6162 | info@trtllc.com |
| 04260484571601 | OrthoGold100® - Indications for UseThe OrthoGold100® is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue | (404) 402-6844 | info@trtllc.com |
| 04260484571687 | VIASURE - Indications for UseThe VIASURE is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue | (404) 402-6844 | info@trtllc.com |
| 04260484571823 | Dermagold100 - The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year 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 is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s). | (888) 862-6162 | info@trtllc.com |
| 04260484573001 | MTS - The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS | (404) 402-6844 | info@trtllc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 25145 | 1954768749 | K233937 | OW100S | PZL | 2024-07-09 |
| 25145 | 1054137877 | K231710 | OW100S | PZL | 2023-09-01 |
| 25145 | 1524711516 | K213120 | OW100S (model OW100S-US) | ISA | 2022-10-12 |
| 25145 | 1588022986 | K210451 | OrthoGold 100 | ISA | 2021-05-05 |
| 25145 | 1211296524 | K200926 | OrthoGold 100 | PZL | 2020-08-28 |
| 25145 | 1277023260 | K191961 | OrthoGold | PZL | 2019-11-26 |
| 25145 | 1113620358 | K182682 | OrthoGold 100 | ISA | 2018-12-21 |
| 25145 | 1081800941 | K062081 | LITHOGOLD | LNS | 2006-11-02 |
Product Codes Associated With Registrations#
GUDID#
ChiroGold - The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circulation - Activation of connective tissue.
2025-06-30
Softwave Gold Li - 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)
2024-08-30
Softwave Gold Li - 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)
2024-08-30
OrthoGold100® - Indications for UseThe OrthoGold100® is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue
2019-01-23
VIASURE - Indications for UseThe VIASURE is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue
2021-07-01
Dermagold100 - The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year 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 is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
2023-09-11
MTS - The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS
2016-09-24
OW100S - Indications for Use The OW100S (model OW100S-US) is intended for:- Relief of minor muscle aches and pains- Temporary increase in local blood circulation- Activation of connective tissue
2022-11-29
DermaGold100® - The DermaGold100® is intended for treatment of - diabetic footulcers- superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
2020-03-31