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: ● It is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. ● OTC TENS, Patch type. FDA UDI
Model / Reference: WL-2406 FDA UDI
Description: ● It is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. ● OTC TENS, Patch type. FDA UDI

Identifiers

Primary DI / UDI-DI: 04719872264064 FDA UDI
510(k) Number: K133723 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

K133723 also covers:

CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

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 84b54180-8d0e-49f0-a6e9-0ca1fa9889ce 35 fields · synced Jun 1, 2026