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510(k) K904069

BRODA NURSING CARE CHAIR by Broda Ent., Inc. — Product Code INN

K904069 is an FDA 510(k) premarket notification submitted by Broda Ent., Inc. for the device "BRODA NURSING CARE CHAIR". The FDA issued a decision of Substantially Equivalent on September 17, 1990. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100. Broda Ent., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1990
Date Received
September 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Adjustable, Mechanical
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Broda Ent., Inc.

  • K032133 — BRODA MODEL 587 MANUAL WHEELCHAIR (July 21, 2003)
  • K905671 — BRODA WHEELCHAIR (December 31, 1990)

Other clearances for product code INN

  • K945650 — SPIFFY (December 19, 1994)
  • K942397 — THERADAPT HIGHCHAIR/STROLLER INSERT (June 22, 1994)
  • K930520 — THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (March 24, 1993)
  • K923753 — ABLE GENERATION THERAPY TILT BENCH (January 29, 1993)
  • K923750 — ABLE GENERATION BOOSTER CHAIR (January 29, 1993)
  • K923752 — ABLE GENERATION PLAY CHAIR (January 29, 1993)
  • K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZER (July 21, 1992)
  • K922061 — CHAIR, ADJUSTABLE, MECHANICAL (May 26, 1992)
  • K921272 — ACTIVITY CHAIR (April 7, 1992)
  • K902951 — SHOWER-A-WAY (July 25, 1990)

FDA data resources