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ErGO-Scan System

by Tekscan, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberB970ER10 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ErGO-Scan
Generic Name
Body-surface pressure mapping system
Model / Ref / Catalog
ErGO-Scan System, ER1
Primary DI / UDI-DI
B970ER10
FDA Product Code
JFC
GMDN Term
Body-surface pressure mapping system
Device Class
Class I
Regulation Number
890.1600
GUDID distribution status
In Commercial Distribution

Other devices from Tekscan, Inc.

See all devices from Tekscan, Inc. →

Properties

  • Premarket Exempt
  • Manufacturing Date

Other properties (12)

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