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: For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7) For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6) FDA UDI
Model / Reference: WL-2405 FDA UDI
Description: For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7) For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6) FDA UDI

Identifiers

Primary DI / UDI-DI: 04719872264057 FDA UDI
510(k) Number: K141299 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

K141299 also covers:

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 2abc1a23-3eec-409c-a93c-2995c81d5804 35 fields · synced Jun 6, 2026