Well-Life

FDA UDI

Class II (US FDA UDI)

by Well-Life Healthcare, Inc.

Identity

Trade Name: WELL-LIFE FDA UDI
Generic Name: Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name: ● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic relief of chronic intractable pain (TENS), and EMS intended for: Relax muscle spasms/ Prevent or retard disuse atrophy/ Increase local blood circulation/ Re-educate muscles/ Maintain or increase the range of motion FDA UDI
Model / Reference: WL-2204 FDA UDI
Description: ● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic relief of chronic intractable pain (TENS), and EMS intended for: Relax muscle spasms/ Prevent or retard disuse atrophy/ Increase local blood circulation/ Re-educate muscles/ Maintain or increase the range of motion FDA UDI

Identifiers

Primary DI / UDI-DI: 04719872262046 FDA UDI
510(k) Number: K033857 FDA UDI
FDA Product Code: LIH FDA UDI
GMDN Term: Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Well-Life by Well-Life Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K033857 also covers:

Grafco — GF Health Products, Inc
Grafco — GF Health Products, Inc

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 II	Pending data

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Manufacturer

Manufacturer: Well-Life Healthcare, Inc.

Sources (1)

FDA UDI e436e15d-1c55-4346-8c4d-8544ec1e6b2e 35 fields · synced May 30, 2026