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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 Powered Muscle Stimulator , analog type.  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-2104 FDA UDI
Description
 Well-Life Powered Muscle Stimulator , analog type.  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
04719872261049 FDA UDI
510(k) Number
K013768 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Well-Life Healthcare, Inc.

Sources (1)

  • FDA UDI e38201d2-8e46-40c6-97bb-40cbca60ef17 35 fields · synced May 30, 2026