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UltraPoly 2x4 7B0284

by Dynatronics Corp.

UltraPoly 2x4 7B0284 is a Class II device made by Dynatronics Corp., cleared under FDA 510(k) K130987 on 17 Jul 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10660584000680), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K130987

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 Number10660584000680 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130987 Date17 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130987 decided 17 Jul 2013 Active
  • FDA GUDID UDI-DI 10660584000680 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130987
  2. Listed FDA GUDID 10660584000680

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UltraPoly 2"x4"
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / reference
7B0284
Primary DI / UDI-DI
10660584000680
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
Not in Commercial Distribution
Size
Area/Surface Area — 8 Square inch

Related devices

Cleared under the same submission (K130987)

and 8 more cleared under K130987

Similar devices

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

Other devices from Dynatronics Corp.

See all devices from Dynatronics Corp. →

Properties

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