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RT600-Sl

by Restorative Therapies, Inc.

RT600-Sl is a Class II device made by Restorative Therapies, Inc., cleared under FDA 510(k) K103366 on 4 Apr 2011 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI FA211509), 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) K103366

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 NumberFA211509 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103366 Date4 Apr 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103366 decided 4 Apr 2011 Active
  • FDA GUDID UDI-DI FA211509 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103366
  2. Listed FDA GUDID FA211509

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RT600
Generic name
Physical therapy transcutaneous electrical stimulation system, line-powered
Model / reference
RT600-SL
Primary DI / UDI-DI
FA211509
510(k) Number
FDA product code
GZI
GMDN term
Physical therapy transcutaneous electrical stimulation system, line-powered
Device class
Class II
Regulation number
882.5810
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GZI (Stimulator, Neuromuscular, External Functional).

Other devices from Restorative Therapies, Inc.

See all devices from Restorative Therapies, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)