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iSD900 Motor

by Nakanishi Inc.

iSD900 Motor is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K110278 on 15 Feb 2012 and listed in FDA GUDID since 19 Jun 2020 (UDI-DI 04560264521865), 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) K110278

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 Number04560264521865 UDI-DI Date19 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110278 Date15 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110278 decided 15 Feb 2012 Active
  • FDA GUDID UDI-DI 04560264521865 listed 19 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110278
  2. Listed FDA GUDID 04560264521865

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iSD900
Generic name
Power tool torque control unit
Model / reference
iSD900 Motor
Primary DI / UDI-DI
04560264521865
510(k) Number
FDA product code
EKX
GMDN term
Power tool torque control unit
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Power tool torque control unit

Cleared under the same submission (K110278)

Similar devices

Also classified as Power tool torque control unit.

Similar devices

Other devices filed under FDA product code EKX (Handpiece, direct drive, ac-powered).

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

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