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510(k) K884165

MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS by Spark Instruments & Academics, Inc. — Product Code LBB

K884165 is an FDA 510(k) premarket notification submitted by Spark Instruments & Academics, Inc. for the device "MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS". The FDA issued a decision of Substantially Equivalent on October 26, 1988. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240. Spark Instruments & Academics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1988
Date Received
October 4, 1988
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 Spark Instruments & Academics, Inc.

  • K861396 — HANDHELD DYNAMOMETER, MODEL #160 AND #111 (May 2, 1986)

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