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510(k) K830974

SUTTER CPM 5000 by Sutter Biomedical, Inc. — Product Code JFA

K830974 is an FDA 510(k) premarket notification submitted by Sutter Biomedical, Inc. for the device "SUTTER CPM 5000". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Sutter Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 28, 1983
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 Sutter Biomedical, Inc.

  • K875249 — SUTTER PHALANGEAL CAP (February 3, 1988)
  • K870200 — SUTTER FINGER JOINT PROSTHESIS (October 9, 1987)
  • K861983 — SUTTER LESSER METATARSAL CAP (September 8, 1986)
  • K850274 — SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT (April 25, 1985)
  • K830649 — SUTTER CPM 2000 (March 17, 1983)
  • K823539 — SUTTER CPM (January 14, 1983)
  • K820813 — LESSER METATARSAL PHALANG. JOINT PROSTH (May 21, 1982)
  • K820083 — SUTTER CPM (January 28, 1982)
  • K812691 — SILICONE IMPLANTS (November 16, 1981)
  • K802342 — PROXIMAL INTERPHALANGEAL JOINT IMPLANT (October 14, 1981)

Other clearances for product code JFA

  • K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H. (May 11, 1995)
  • 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)

FDA data resources