FDA.reportPublic FDA data

OW100S

Primary DI
04260484571625
Brand
OW100S
Company
MTS Medical AG
Model
OW100S-US
Catalog number
1000021
Device description
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
Published
2022-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04260484571632PackageGS11In Commercial Distribution
04260484571625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484571632042604845716324260484571632
04260484571625042604845716254260484571625

GMDN Terms#

Term, Definition table
TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. 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 Pressure82 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
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
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484571281ChiroGoldOW100S-US10000292025-06-30
04260484571298ChiroGoldOW100S-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
04260484571649DermaGold100®OW100-US10000142020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00810140061379RENPHOJoicom CorporationISA2024-11-19
00810140061386RENPHOJoicom CorporationISA2024-11-19
00810140061393RENPHOJoicom CorporationISA2024-11-19
00810140061409RENPHOJoicom CorporationISA2024-11-19
00810140061416RENPHOJoicom CorporationISA2024-11-19
00810140061447RENPHOJoicom CorporationISA2024-11-19
00810140061690RENPHOJoicom CorporationISA2024-11-19
00810140061706RENPHOJoicom CorporationISA2024-11-19
00810140061768RENPHOJoicom CorporationISA2024-11-19
00810140061782RENPHOJoicom CorporationISA2024-11-19
00810140061799RENPHOJoicom CorporationISA2024-11-19
00810140061805RENPHOJoicom CorporationISA2024-11-19
00810140061812RENPHOJoicom CorporationISA2024-11-19