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510(k) K923965

NK GRASP SENSOR, MODEL GA002 by Nk Biotechnical Engineering Co. — Product Code LBB

K923965 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Engineering Co. for the device "NK GRASP SENSOR, MODEL GA002". The FDA issued a decision of Substantially Equivalent on May 12, 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
May 12, 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)
  • K923963 — NK DIGI-GRIP SENSOR, MODEL DGR001 (March 31, 1993)
  • K921266 — NK MEDICAL MICROMETER, MODEL MC001 (July 14, 1992)
  • K921268 — NK DYNA-GRIP SENSOR, MODEL DG001 (July 14, 1992)
  • 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)
  • K914057 — NK PINCH SENSOR, MODEL PA001 (December 9, 1991)
  • K914056 — NK PINCH SENSOR, MODEL PF002 (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