OW100S

Basic Information

• Brand Name: OW100S
• Primary DI: 04260484571625
• Version / Model: OW100S-US
• Catalog Number: 1000021
• Company Name: MTS Medical UG (haftungsbeschränkt)
• Labeler DUNS: 342585299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-29
• Public Version: 1
• Public Version Date: 2022-12-07
• Public Version Status: New
• Public Device Record Key: a15acd49-4a3d-46e0-8fd0-83a8df6a0632

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35538	Large-area electric massager	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260484571625	GS1
Package	04260484571632	GS1	Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K213120	000

Device Sizes

Type	Value	Unit	Text
Weight	21	Kilogram
Depth	459	Millimeter
Width	400	Millimeter
Height	218	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 82 – 106 KiloPascal