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510(k) K860037

SUSPENDER ORTHOPEDIC SUSPENSION DEVICE by Comfortex, Inc. — Product Code HST

K860037 is an FDA 510(k) premarket notification submitted by Comfortex, Inc. for the device "SUSPENDER ORTHOPEDIC SUSPENSION DEVICE". The FDA issued a decision of Substantially Equivalent on January 21, 1986. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Comfortex, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
January 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

Other clearances by Comfortex, Inc.

  • K855179 — TRANSFER-TRAX (TM) SPLINT TRACTION (January 21, 1986)
  • K855181 — COMFORTEX WHEELCHAIR CUSHION (January 13, 1986)
  • K854270 — MURPHY ADJUSTABLE SPLINT (December 9, 1985)

Other clearances for product code HST

  • K162702 — Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Dec (December 30, 2016)
  • K110858 — LO-BAK TRAX (August 2, 2011)
  • K984190 — BACK-ON-TRAC, MODEL 101BOT (March 15, 1999)
  • K872121 — K AND D HOME TRACT (August 12, 1987)
  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)
  • K870125 — EXTREMITY ELEVATOR (February 4, 1987)
  • K870102 — TUPPER TROLLEY (February 3, 1987)
  • K864765 — MODEL 668, TRACTION SPLINT, ADULT (December 17, 1986)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K855179 — TRANSFER-TRAX (TM) SPLINT TRACTION (January 21, 1986)

FDA data resources