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510(k) K942397

THERADAPT HIGHCHAIR/STROLLER INSERT by Theradapt Products, Inc. — Product Code INN

K942397 is an FDA 510(k) premarket notification submitted by Theradapt Products, Inc. for the device "THERADAPT HIGHCHAIR/STROLLER INSERT". The FDA issued a decision of Substantially Equivalent on June 22, 1994. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100. Theradapt Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1994
Date Received
May 19, 1994
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 Theradapt Products, Inc.

  • K930520 — THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (March 24, 1993)
  • K926026 — DESKS (March 24, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926025 — CHAIRS (March 22, 1993)

Other clearances for product code INN

  • K945650 — SPIFFY (December 19, 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)
  • K923750 — ABLE GENERATION BOOSTER 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