Home / 510(k) Clearances / K945650

510(k) K945650

SPIFFY by Thames Valley Children'S Centre — Product Code INN

K945650 is an FDA 510(k) premarket notification submitted by Thames Valley Children'S Centre for the device "SPIFFY". The FDA issued a decision of Substantially Equivalent on December 19, 1994. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1994
Date Received
November 17, 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 for product code INN

  • K942397 — THERADAPT HIGHCHAIR/STROLLER INSERT (June 22, 1994)
  • K930520 — THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (March 24, 1993)
  • K923750 — ABLE GENERATION BOOSTER CHAIR (January 29, 1993)
  • K923752 — ABLE GENERATION PLAY CHAIR (January 29, 1993)
  • K923753 — ABLE GENERATION THERAPY TILT BENCH (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