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510(k) K945221

SUTTER MODEL 6000 HAND CPM DEVICE by Sutter Corp. — Product Code BXB

K945221 is an FDA 510(k) premarket notification submitted by Sutter Corp. for the device "SUTTER MODEL 6000 HAND CPM DEVICE". The FDA issued a decision of Substantially Equivalent on February 27, 1995. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Sutter Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1995
Date Received
October 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Sutter Corp.

  • K943354 — SUTTER HAMMERTOE JOINT PROSTHESIS (June 12, 1995)
  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)
  • K924654 — FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT (February 22, 1993)
  • K914860 — SUTTER MODEL 10000 LEG CPM DEVICE (January 8, 1992)
  • K902707 — MODEL 9000 AT ANKLE CPM DEVICE (July 25, 1990)
  • K890607 — SUTTER HOSPITAL CPM (February 27, 1989)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources