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510(k) K850082

HAND HELD GONIOMETER by Chattanooga Group, Inc. — Product Code KQW

K850082 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "HAND HELD GONIOMETER". The FDA issued a decision of Substantially Equivalent on April 4, 1985. The device falls under product code KQW (Goniometer, Nonpowered), a Class I device regulated under 21 CFR 888.1520. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1985
Date Received
January 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Nonpowered
Device Class
Class I
Regulation Number
888.1520
Review Panel
NE
Submission Type

Other clearances by Chattanooga Group, Inc.

  • K090632 — COMPEX REHAB (June 1, 2009)
  • K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 (March 18, 2009)
  • K083140 — COMPEX SPORT PLUS (February 9, 2009)
  • K070425 — VITALSTIM EXPERIA (June 11, 2007)
  • K053223 — TRITON/TRU-TRAC/TX/TRITON DTS TRACTION (February 24, 2006)
  • K051938 — TRITON/TRU-TRAC/TX TRACTION DEVICES (September 21, 2005)
  • K040662 — VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) (September 8, 2004)
  • K040285 — VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORT (April 12, 2004)
  • K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (December 11, 2003)
  • K031116 — VECTRA (INTELECT) EPR ULTRASOUND (December 3, 2003)

Other clearances for product code KQW

  • K926237 — O'BRIEN GONIOMETER (August 2, 1993)
  • K901744 — DOBBHOFF(R) RETRIEVAL FORCEPS (July 3, 1990)
  • K870767 — THE (CROM) TESTER (March 17, 1987)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K812778 — THE TELOS EQUIPMENT (December 8, 1981)
  • K810441 — UNIVERSAL GONIMETER (February 27, 1981)
  • K801717 — BK-7511 BRASS GONIOMETER (August 4, 1980)
  • K801716 — BK-7505 RADIOPAQUE GONIOMETER, 8 (August 4, 1980)
  • K801718 — BK-7513 STAINLESS STEEL GONIOMETER (August 4, 1980)
  • K801715 — BK-7497 BULB DYNAMOMETER (August 4, 1980)

FDA data resources