FDA.reportPublic FDA data

ChiroGold

Primary DI
04260484571298
Brand
ChiroGold
Company
MTS Medical AG
Model
OW100S-US
Catalog number
1000029
Device description
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.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213120000OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt2022-10-12ISA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260484571298PackageGS11In Commercial Distribution
04260484571281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484571298042604845712984260484571298
04260484571281042604845712814260484571281

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding electric massagerAn electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth459Millimeter
Height218Millimeter
Weight21Kilogram
Width400Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 862-6162info@trtllc.com

Regulatory Flags#

DUNS number
342585299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484571281ChiroGoldOW100S-US10000292025-06-30
04260484571267Softwave Gold LiOW100S-US10000242024-08-30
04260484571274Softwave Gold LiOW100S-US10000242024-08-30
04260484571601OrthoGold100®OW100-US10000132019-01-23
04260484571687VIASUREOW100-US10000152021-07-01
04260484571823Dermagold100OW100S-US10000222023-09-11
04260484573001MTSLG38038000002016-09-24
04260484571625OW100SOW100S-US10000212022-11-29
04260484571649DermaGold100®OW100-US10000142020-03-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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