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Body Harness-Medium E3-M

by Electro-Cap International Inc

Body Harness-Medium E3-M is a Class II device made by Electro-Cap International Inc, cleared under FDA 510(k) K112319 on 27 Jan 2012 and listed in FDA GUDID since 17 Oct 2016 (UDI-DI 00811478011753), active as of 22 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 22 Oct 2026

Documents

510(k) K112319

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811478011753 UDI-DI Date17 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112319 Date27 Jan 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112319 decided 27 Jan 2012 Active
  • FDA GUDID UDI-DI 00811478011753 listed 17 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112319
  2. Listed FDA GUDID 00811478011753

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Body Harness-Medium
Generic name
Analytical scalp lead
Model / Ref / Catalog
E3-M
Primary DI / UDI-DI
00811478011753
510(k) Number
FDA product code
GXY
GMDN term
Analytical scalp lead
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Analytical scalp lead

Cleared under the same submission (K112319)

and 8 more cleared under K112319

Similar devices

Also classified as Analytical scalp lead.

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Electro-Cap International Inc

See all devices from Electro-Cap International Inc →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)