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510(k) K791021

MUSCLE TESTING GUN by The Orthodyn Co. — Product Code HRW

K791021 is an FDA 510(k) premarket notification submitted by The Orthodyn Co. for the device "MUSCLE TESTING GUN". The FDA issued a decision of Substantially Equivalent on June 15, 1979. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1979
Date Received
May 30, 1979
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 for product code HRW

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  • K970870 — DIGIT-GRIP WITH LCD (DGR002) (May 2, 1997)
  • 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)
  • K790302 — PRESSURE MONITOR, MODEL 212 (March 21, 1979)
  • K772415 — DYNAMETER 50 LB. (January 5, 1978)
  • K772413 — PINCH GUAGE (January 5, 1978)

FDA data resources