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Sensus Se-SY4

by Neurometrix, Inc.

Sensus Se-SY4, a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Neurometrix, Inc., was cleared under FDA 510(k) K130919 on 2 Jul 2013 and listed in FDA GUDID on 9 Sep 2016 (UDI-DI 00851221006339); the registry lists it as not in commercial distribution (GUDID) as of 22 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 22 Oct 2026

Documents

510(k) K130919

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 Number00851221006339 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130919 Date2 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130919 decided 2 Jul 2013 Active
  • FDA GUDID UDI-DI 00851221006339 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130919
  2. Listed FDA GUDID 00851221006339

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sensus
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Model / reference
SE-SY4
Description
SENSUS System, 4-lead configuration 2 SE-001, SE-C01, charger, cable
Primary DI / UDI-DI
00851221006339
FDA product code
NUH
GMDN term
Analgesic transcutaneous electrical nerve stimulation system
Device class
Class II
Regulation number
882.5890
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Analgesic transcutaneous electrical nerve stimulation system

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Other devices from Neurometrix, Inc.

See all devices from Neurometrix, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)