Skip to content

Estcarbon P102

by Erismet OU 2 variants

Estcarbon P102 is a Class I device made by Erismet OU, listed in FDA GUDID since 9 Sep 2024 (UDI-DI 04744946012111), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04744946012111 UDI-DI Date9 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Estcarbon
Generic name
Orthotic insole, prefabricated, non-antimicrobial
Model / reference
P102
Description
Recovery Carbon Fiber Insole Women's US Size 9 Men's US Size 8-8.5 9.92 in.
Primary DI / UDI-DI
04744946012111
FDA product code
KYS
GMDN term
Orthotic insole, prefabricated, non-antimicrobial
Device class
Class I
Regulation number
880.6280
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthotic insole, prefabricated, non-antimicrobial

Similar devices in this category

Other devices filed under Orthotic insole, prefabricated, non-antimicrobial.

Other devices from Erismet OU

See all devices from Erismet OU →

Properties

  • Over-the-counter
  • Premarket exempt
  • Manufacturing date
Other properties (12, all answered No)