OW100S 1000021

GUDID 04260484571625

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

MTS Medical UG (haftungsbeschränkt)

Large-area electric massager

• Primary Device ID: 04260484571625
• NIH Device Record Key: a15acd49-4a3d-46e0-8fd0-83a8df6a0632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OW100S
• Version Model Number: OW100S-US
• Catalog Number: 1000021
• Company DUNS: 342585299
• Company Name: MTS Medical UG (haftungsbeschränkt)
• Device Count: 1
• DM Exempt: true
• 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
• Email: info@trtllc.com

Device Dimensions

• 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
• Storage 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	04260484571625 [Primary]
GS1	04260484571632 [Package]; 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: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by MTS Medical UG (haftungsbeschränkt)

• 04260484571830 - Dermagold100: 2023-09-19 The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer w
• 04260484571625 - OW100S: 2022-12-07Indications 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
• 04260484571625 - OW100S: 2022-12-07 Indications for Use The OW100S (model OW100S-US) is intended for: - Relief of minor muscle aches and pains - Temporary increase
• 04260484571694 - VIASURE: 2021-07-09 Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blo
• 04260484571649 - DermaGold100®: 2020-04-08 The DermaGold100® is intended for treatment of diabetic footulcers
• 4260484573018 - MTS: 2020-04-01 The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold®
• 04260484571618 - OrthoGold100®: 2019-02-25 The OrthoGold100® is intended for the activation of connective tissue.