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510(k) K923750

ABLE GENERATION BOOSTER CHAIR by The Able Generation, Inc. — Product Code INN

K923750 is an FDA 510(k) premarket notification submitted by The Able Generation, Inc. for the device "ABLE GENERATION BOOSTER CHAIR". The FDA issued a decision of Substantially Equivalent on January 29, 1993. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100. The Able Generation, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1993
Date Received
July 28, 1992
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 The Able Generation, Inc.

  • K923751 — ABLE GENERATION DESK (January 29, 1993)
  • K923752 — ABLE GENERATION PLAY CHAIR (January 29, 1993)
  • K923753 — ABLE GENERATION THERAPY TILT BENCH (January 29, 1993)

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)
  • 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)
  • K904069 — BRODA NURSING CARE CHAIR (September 17, 1990)
  • K902951 — SHOWER-A-WAY (July 25, 1990)

FDA data resources