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bt-nano ULTRA

by Micro Current Technology, Inc.

bt-nano ULTRA is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Micro Current Technology, Inc., cleared under FDA 510(k) K181062 on 18 Jul 2018 and listed in FDA GUDID since 30 Jan 2019 (UDI-DI 00817076010884), 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) K181062

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 Number00817076010884 UDI-DI Date30 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181062 Date18 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181062 decided 18 Jul 2018 Active
  • FDA GUDID UDI-DI 00817076010884 listed 30 Jan 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181062
  2. Listed FDA GUDID 00817076010884

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
bt-nano
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Model / reference
ULTRA
Primary DI / UDI-DI
00817076010884
510(k) Number
FDA product code
NFO
GMDN term
Analgesic transcutaneous electrical nerve stimulation system
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Analgesic transcutaneous electrical nerve stimulation system

Cleared under the same submission (K181062)

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Other devices from Micro Current Technology, Inc.

See all devices from Micro Current Technology, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)