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510(k) K945803

THERMAFLEX, MODEL SD 55 C.P.M.H. by Burke Neutech, Inc. — Product Code JFA

K945803 is an FDA 510(k) premarket notification submitted by Burke Neutech, Inc. for the device "THERMAFLEX, MODEL SD 55 C.P.M.H.". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Burke Neutech, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
November 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Finger, Powered
Device Class
Class I
Regulation Number
890.5410
Review Panel
PM
Submission Type

Other clearances by Burke Neutech, Inc.

  • K955326 — SPORTS CONTRAST THERAPY SYSTEM ST 7000 (April 10, 1996)
  • K952117 — EPILATOR (October 19, 1995)
  • K943497 — CONTRAST 7000 THERAPY SYSTEM (June 7, 1995)
  • K942926 — NEURO-AIDE (August 3, 1994)
  • K940160 — TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM (May 27, 1994)
  • K926151 — LSI6000 THERMAL THERAPY SYSTEM (May 26, 1993)

Other clearances for product code JFA

  • K931016 — JACE MODEL H440 HAND CPM DEVICE (June 22, 1994)
  • K933418 — HAND THERAPY ASSOST (April 28, 1994)
  • K921351 — JACE MODEL PM-410 HAND CPM DEVICE (May 4, 1992)
  • K900794 — MOBILIMB H3 HAND CPM UNIT (March 2, 1990)
  • K900581 — DANNIFLEX CPM 880(TM) (February 20, 1990)
  • K880686 — TORONTO/MOBILIMB HAND C.P.M. (February 26, 1988)
  • K880336 — MOBILIMB HAND C.P.M. UNIT (February 16, 1988)
  • K860714 — ACE AIM - CPM HAND UNIT (March 27, 1986)
  • K844033 — MOBILIMB HAND UNIT (November 27, 1984)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)

FDA data resources