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PainAway Pro RTLAGF-910

by Drive Devilbiss Healthcare

PainAway Pro RTLAGF-910 is a transcutaneous electrical stimulation lead (FDA Class II) made by Drive Devilbiss Healthcare, cleared under FDA 510(k) K102598 on 13 May 2011 and listed in FDA GUDID since 1 Jul 2016 (UDI-DI 00822383549408), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K102598

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00822383549408 UDI-DI Date1 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102598 Date13 May 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102598 decided 13 May 2011 Active
  • FDA GUDID UDI-DI 00822383549408 listed 1 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102598
  2. Listed FDA GUDID 00822383549408

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PainAway Pro
Generic name
Transcutaneous electrical stimulation lead
Model / reference
RTLAGF-910
Primary DI / UDI-DI
00822383549408
510(k) Number
FDA product code
NGX, NUH
GMDN term
Transcutaneous electrical stimulation lead
Device class
Class II
Regulation number
890.5850, 882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation systemTranscutaneous electrical stimulation lead

Cleared under the same submission (K102598)

and 8 more cleared under K102598

Similar devices

Other devices filed under FDA product code NGX (STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING).

Other devices from Drive Devilbiss Healthcare

See all devices from Drive Devilbiss Healthcare →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)