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510(k) K780617

EQUALIZER by Ballert Orthopedic Corp. — Product Code IPG

K780617 is an FDA 510(k) premarket notification submitted by Ballert Orthopedic Corp. for the device "EQUALIZER". The FDA issued a decision of Substantially Equivalent on April 18, 1978. The device falls under product code IPG (Shoe, Cast), a Class I device regulated under 21 CFR 890.3025. Ballert Orthopedic Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1978
Date Received
April 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoe, Cast
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type

Other clearances by Ballert Orthopedic Corp.

  • K771988 — VERTETRAC (February 1, 1979)

Other clearances for product code IPG

  • K024279 — NESS CHILDREN SYSTEM (February 5, 2003)
  • K790652 — TOGUARD (April 4, 1979)
  • K781363 — CAST SHOE (August 14, 1978)
  • K760575 — ROCKER-SOLE CAST SANDAL (October 6, 1976)
  • K760578 — BALANCED CAST SOLE (September 27, 1976)

FDA data resources