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510(k) K902951

SHOWER-A-WAY by Tri-S-Sales and Mfg. — Product Code INN

K902951 is an FDA 510(k) premarket notification submitted by Tri-S-Sales and Mfg. for the device "SHOWER-A-WAY". The FDA issued a decision of Substantially Equivalent on July 25, 1990. 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
July 25, 1990
Date Received
July 5, 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 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)
  • K923750 — ABLE GENERATION BOOSTER CHAIR (January 29, 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)

FDA data resources