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510(k) K771631

WHEELCHAIR SAFETY BELT by Medical Restraints, Inc. — Product Code KNN

K771631 is an FDA 510(k) premarket notification submitted by Medical Restraints, Inc. for the device "WHEELCHAIR SAFETY BELT". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Medical Restraints, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1977
Date Received
August 26, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type

Other clearances by Medical Restraints, Inc.

  • K771629 — HAND RESTRAINT (September 30, 1977)
  • K771630 — LIMB RESTRAINT (September 30, 1977)
  • K771636 — BODY RESTRAINT (September 30, 1977)
  • K771715 — PELVIC WHEELCHAIR RESTRAINT (September 28, 1977)
  • K771632 — FINGER MITT RESTRAINT (September 28, 1977)
  • K771635 — FOOT ELEVATOR (September 28, 1977)
  • K771634 — VEST RESTRAINT (September 28, 1977)
  • K771676 — FOOT DROP BOOT (September 20, 1977)
  • K771633 — HEEL PROTECTOR (September 12, 1977)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942312 — ALDEN LINEAGE WHEELCHAIR CUSHION (May 26, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 1994)
  • K933051 — ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (October 12, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K925980 — PM (March 24, 1993)

FDA data resources