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510(k) K970870

DIGIT-GRIP WITH LCD (DGR002) by Nk Biotechnical Corp. — Product Code HRW

K970870 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Corp. for the device "DIGIT-GRIP WITH LCD (DGR002)". The FDA issued a decision of Substantially Equivalent on May 2, 1997. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250. Nk Biotechnical Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1997
Date Received
March 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Nonpowered
Device Class
Class I
Regulation Number
888.1250
Review Panel
NE
Submission Type

Other clearances by Nk Biotechnical Corp.

  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)

Other clearances for product code HRW

  • K971407 — JTECH COMMANDER AND ALGOMETER (April 20, 1998)
  • K894557 — LIGHTSCOPE SET (August 7, 1989)
  • K861396 — HANDHELD DYNAMOMETER, MODEL #160 AND #111 (May 2, 1986)
  • K821631 — PINCH GAUGE, 0-301 LBS. (June 11, 1982)
  • K812343 — PINCH METER (September 11, 1981)
  • K801719 — BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG (August 4, 1980)
  • K791021 — MUSCLE TESTING GUN (June 15, 1979)
  • K790302 — PRESSURE MONITOR, MODEL 212 (March 21, 1979)
  • K772415 — DYNAMETER 50 LB. (January 5, 1978)
  • K772413 — PINCH GUAGE (January 5, 1978)

FDA data resources