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Electro-Mesh Panel EMSP44

by Prizm Medical, Inc.

Electro-Mesh Panel EMSP44 is a transcutaneous electrical stimulation electrode (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Prizm Medical, Inc., cleared under FDA 510(k) K944487 on 21 Feb 1995 and listed in FDA GUDID since 6 Jun 2024 (UDI-DI B872EMSP440), active as of 23 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 23 Oct 2026

Documents

510(k) K944487

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB872EMSP440 UDI-DI Date6 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK944487 Date21 Feb 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K944487 decided 21 Feb 1995 Active
  • FDA GUDID UDI-DI B872EMSP440 listed 6 Jun 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K944487
  2. Listed FDA GUDID B872EMSP440

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Electro-Mesh Panel
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / reference
EMSP44
Primary DI / UDI-DI
B872EMSP440
510(k) Number
FDA product code
GXY
GMDN term
Transcutaneous electrical stimulation electrode, single-use
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Prizm Medical, Inc.

See all devices from Prizm Medical, Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)