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TeleRehab Computer

by Scottcare Corporation, the

TeleRehab Computer (101819) is a desktop computer (FDA Class II; FDA product code DRG, Transmitters And Receivers, Physiological Signal, Radiofrequency) made by Scottcare Corporation, the, cleared under FDA 510(k) K050778 on 13 Apr 2005 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00856298006275), active as of 21 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 21 Oct 2026

Documents

510(k) K050778

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856298006275 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050778 Date13 Apr 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050778 decided 13 Apr 2005 Active
  • FDA GUDID UDI-DI 00856298006275 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050778
  2. Listed FDA GUDID 00856298006275

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Desktop computer
Model / Ref / Catalog
TeleRehab Computer, 101819
Primary DI / UDI-DI
00856298006275
510(k) Number
FDA product code
DRG
GMDN term
Desktop computer
Device class
Class II
Regulation number
870.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Desktop computer

Cleared under the same submission (K050778)

and 5 more cleared under K050778

Other devices from Scottcare Corporation, the

See all devices from Scottcare Corporation, the →

Properties

  • Serial number
Other properties (14, all answered No)