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510(k) K914062

NK DEXTERITLY BOARD, MODEL BX001 by Nk Biotechnical Engineering Co. — Product Code KQX

K914062 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Engineering Co. for the device "NK DEXTERITLY BOARD, MODEL BX001". The FDA issued a decision of Substantially Equivalent on December 9, 1991. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Nk Biotechnical Engineering Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
September 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
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)
  • K923963 — NK DIGI-GRIP SENSOR, MODEL DGR001 (March 31, 1993)
  • K921268 — NK DYNA-GRIP SENSOR, MODEL DG001 (July 14, 1992)
  • K921266 — NK MEDICAL MICROMETER, MODEL MC001 (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)

Other clearances for product code KQX

  • K011827 — ORTELIUS 800 (August 28, 2001)
  • K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (July 9, 1997)
  • K962377 — 3D-SPINE (September 3, 1996)
  • K961212 — SPINAL TOUCH (June 12, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (May 15, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)

FDA data resources