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PainAway Pro

FDA UDI

Class II (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
PainAway Pro FDA UDI
Generic Name
Transcutaneous electrical stimulation lead FDA UDI
Device Name
BackSzLong-Last Elctrde,RTLAGF-900 FDA UDI
Model / Reference
RTLAGF-920 FDA UDI
Description
BackSzLong-Last Elctrde,RTLAGF-900 FDA UDI

Identifiers

Primary DI / UDI-DI
00822383549415 FDA UDI
510(k) Number
K102598 FDA UDI
FDA Product Code
NUH FDA UDI
NGX FDA UDI
GMDN Term
Transcutaneous electrical stimulation lead FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

PainAway Pro by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102598 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drive Devilbiss Healthcare

Sources (1)

  • FDA UDI d0078d04-1b7c-4454-b749-c67e23d2f564 35 fields · synced Jun 8, 2026