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EleGARD SYSELG002

by Advancedcpr Solutions, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB716DEVELG002 UDI-DI Date29 Aug 2022ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EleGARD
Generic Name
Freestanding patient positioner, reusable
Model / Ref / Catalog
SYSELG002
Primary DI / UDI-DI
B716DEVELG002
510(k) Number
FDA Product Code
DMR, FOA
GMDN Term
Freestanding patient positioner, reusable
Device Class
Class I
Regulation Number
862.3240, 880.6080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Freestanding patient positioner, reusable

Other devices from Advancedcpr Solutions, LLC

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No