Home / 510(k) Clearances / K923963

510(k) K923963

NK DIGI-GRIP SENSOR, MODEL DGR001 by Nk Biotechnical Engineering Co. — Product Code LBB

K923963 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Engineering Co. for the device "NK DIGI-GRIP SENSOR, MODEL DGR001". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240. Nk Biotechnical Engineering Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
August 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type

Other clearances by Nk Biotechnical Engineering Co.

  • K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (August 11, 1994)
  • K923964 — NK GRASP SENSOR, MODEL GA001 (May 12, 1993)
  • K923965 — NK GRASP SENSOR, MODEL GA002 (May 12, 1993)
  • K921266 — NK MEDICAL MICROMETER, MODEL MC001 (July 14, 1992)
  • K921268 — NK DYNA-GRIP SENSOR, MODEL DG001 (July 14, 1992)
  • K914059 — NK DEVIATION SENSOR, MODEL DV001 (December 9, 1991)
  • K914062 — NK DEXTERITLY BOARD, MODEL BX001 (December 9, 1991)
  • K914055 — PINCH SENSOR, MODEL PF001 (December 9, 1991)
  • K914054 — NK GRASP SENSOR, MODEL GR001 (December 9, 1991)
  • K914060 — RANGE OF MOTION SENSOR, MODEL RM001 (December 9, 1991)

Other clearances for product code LBB

  • K162412 — Hoggan Scientific® microFET2™ (March 9, 2017)
  • K073154 — FACTS HAND AND PINCH GRIP COMBO (February 14, 2008)
  • K052309 — DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 (September 27, 2005)
  • K042889 — DYNAMOMETER - MODEL FCE AND MODEL MSC (November 16, 2004)
  • K012492 — KADANCE 2000 (November 2, 2001)
  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)
  • K980363 — ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) (April 16, 1998)
  • K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (February 3, 1997)
  • K964685 — DYNAMOMETER (January 27, 1997)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)

FDA data resources