Home / 510(k) Clearances / K810222

510(k) K810222

LIMB ORHTOSIS by Medical Design & Manufacturing Corp. — Product Code ITQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1981
Date Received
January 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Knee, External Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Medical Design & Manufacturing Corp.

  • K911911 — MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM (March 20, 1992)
  • K914384 — MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE (November 13, 1991)
  • K911366 — PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE (September 27, 1991)
  • K902822 — MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE (December 19, 1990)
  • K895604 — SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES (October 13, 1989)
  • K880492 — INTERCEPT T.E.N.S. DEVICE (April 18, 1988)
  • K834138 — HYPO SUTURE (January 27, 1984)
  • K821848 — ASSURE-MALE EXTERNAL INCONTINCE CATHETER (August 10, 1982)
  • K811224 — MINISTIM (June 2, 1981)

Other clearances for product code ITQ

  • K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE (June 24, 1983)
  • K831310 — BRACE C.T. (May 16, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823397 — ANATOMIC FRACTURE BRACE (November 29, 1982)
  • K823159 — DELUXE KNEE IMMOBILIZER (November 10, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K802673 — KNEE BRACE/STABILIZER (November 12, 1980)
  • K780892 — FRACTURE BRACING (June 13, 1978)