Ow100s

FDA UDI

Class I (US FDA UDI)

by MTS Medical AG

Identity

Trade Name: OW100S FDA UDI
Generic Name: Freestanding electric massager FDA UDI
Device Name: 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 FDA UDI
Model / Reference: OW100S-US FDA UDI
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 FDA UDI

Identifiers

Catalog Number: 1000021 FDA UDI
Primary DI / UDI-DI: 04260484571625 FDA UDI
510(k) Number: K213120 FDA UDI
FDA Product Code: ISA FDA UDI
GMDN Term: Freestanding electric massager FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 21 Kilogram FDA UDI
Depth — 459 Millimeter FDA UDI
Width — 400 Millimeter FDA UDI
Height — 218 Millimeter FDA UDI

Category: Freestanding electric massager

Ow100s by MTS Medical AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K213120 also covers:

ChiroGold — MTS Medical AG

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: MTS Medical AG

Sources (1)

FDA UDI a15acd49-4a3d-46e0-8fd0-83a8df6a0632 38 fields · synced Jun 6, 2026