Skip to content

NK Dyna-Grip Sensor, Model DG001

by Nk Biotechnical Engineering Co.

510(k) K921268

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921268 Date14 Jul 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LBB
Device Class
Class II
Regulation
21 CFR Part 888.1240
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NK Dyna-Grip Sensor, Model DG001, is an Ac-Powered Dynamometer, a device designed to measure grip strength. It falls under the classification of a dynamometer, utilising flexure beams and strain sensors arranged in a Wheatstone bridge configuration to quantify hand grip force accurately. This device is categorised under the FDA’s product code LBB and is intended for use in orthopaedic applications.

The NK Dyna-Grip Sensor, Model DG001, is supplied as a reusable, non-sterile device and is classified as a Class II medical device under FDA regulations. It requires an AC power source for operation and is regulated under the FDA’s 510(k) clearance process, with clearance number K921268 granted in 1992. The device is designed for clinical use in orthopaedic settings and adheres to the regulatory requirements outlined in 21 CFR 888.1240.

Other devices from Nk Biotechnical Engineering Co.

See all devices from Nk Biotechnical Engineering Co. →