ChiroGold 1000029
GUDID 04260484571298
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.
MTS Medical AG
Freestanding electric massager| Primary Device ID | 04260484571298 |
| NIH Device Record Key | 846e42fb-f72f-4e03-91bd-d2420d18f5fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ChiroGold |
| Version Model Number | OW100S-US |
| Catalog Number | 1000029 |
| Company DUNS | 342585299 |
| Company Name | MTS Medical AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com | |
| Phone | (888) 862-6162 |
| info@trtllc.com |
Device Dimensions
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
| Weight | 21 Kilogram |
| Depth | 459 Millimeter |
| Width | 400 Millimeter |
| Height | 218 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 82 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260484571281 [Primary] |
| GS1 | 04260484571298 [Package] Contains: 04260484571281 Package: Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213120
FDA Product Code
| ISA | Massager, Therapeutic, Electric |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
Devices Manufactured by MTS Medical AG
| 04260484571298 - ChiroGold | 2025-07-08The 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. |
| 04260484571298 - ChiroGold | 2025-07-08 The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circu |
| 04260484571274 - Softwave Gold Li | 2024-09-09 The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulc |
Trademark Results [ChiroGold]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHIROGOLD 98399718 not registered Live/Pending |
SoftWave Tissue Regeneration Technologies, LLC 2024-02-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.