Norotrode 20 N120

by Myotronics-Noromed, Inc.

Norotrode 20 N120 is an analytical non-scalp cutaneous electrode (FDA Class II; FDA product code IKN, Electromyograph, Diagnostic) made by Myotronics-Noromed, Inc., cleared under FDA 510(k) K013399 on 13 Nov 2001 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI D792N12011), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD792N12011 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK013399	Date13 Nov 2001Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K013399

Across registries

2 registries list this device

FDA 510(k) K013399 decided 13 Nov 2001 Active
FDA GUDID UDI-DI D792N12011 listed 19 Sep 2016 Listed

Timeline

2 dated events

13 Nov 2001 Cleared FDA 510(k) K013399
19 Sep 2016 Listed FDA GUDID D792N12011

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Norotrode 20
Generic name: Analytical non-scalp cutaneous electrode
Model / reference: N120

Primary DI / UDI-DI: D792N12011
510(k) Number: K013399
FDA product code: IKN
GMDN term: Analytical non-scalp cutaneous electrode

Device class: Class II
Regulation number: 890.1375
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)