TimeWaver Frequency

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K212832

by Timewaver Production GmbH

Identity

Trade Name: TimeWaver Frequency FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name: TimeWaver Frequency is an electrical stimulation device that supports the treatment of symptoms of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS). FDA UDI
Model / Reference: REF 0002 FDA UDI
Description: TimeWaver Frequency is an electrical stimulation device that supports the treatment of symptoms of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS). FDA UDI

Identifiers

Catalog Number: 0002 FDA UDI
Primary DI / UDI-DI: 04251784202067 FDA UDI
510(k) Number: K212832 FDA 510(k)FDA UDI
FDA Product Code: IPF FDA 510(k)FDA UDI
GZJ FDA UDI
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 890.5850 FDA 510(k)
Regulation Number: 890.5850 FDA 510(k)FDA UDI
882.5890 FDA UDI
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
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

TimeWaver Frequency by Timewaver Production GmbH — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K212832	Class II	Active

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Manufacturer

Manufacturer: Timewaver Production GmbH

Sources (2)

FDA 510(k) K212832 24 fields · synced Jun 18, 2026
FDA UDI 2170e9de-97b0-457c-9b85-2b66e3e07803 35 fields · synced May 26, 2026