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510(k) K922045

SHOWER CHAIRS by Medical Device Inspection Co., Inc. — Product Code INM

K922045 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "SHOWER CHAIRS". The FDA issued a decision of Substantially Equivalent on May 26, 1992. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1992
Date Received
May 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, With Casters
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Medical Device Inspection Co., Inc.

  • K945826 — J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFT (August 4, 1995)
  • K932072 — JARIT SURGICAL INSTRUMENTS (January 11, 1994)
  • K931594 — THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM (December 21, 1993)
  • K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
  • K933580 — POWER WORK TABLE (November 5, 1993)
  • K933581 — POWERMATIC TREATMENT TABLE (November 5, 1993)
  • K933577 — POWERMATIC EXAMINATION TABLE (September 30, 1993)
  • K912075 — C-SECTION TRAY (April 7, 1992)
  • K914174 — STERILE DISPOSABLE WET SKIN SCRUB TRAY (February 24, 1992)
  • K920403 — XENON ARC ENDOSCOPE LIGHT SOURCE (February 21, 1992)

Other clearances for product code INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K941569 — CAREMOR CLINER (April 26, 1994)
  • K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (September 30, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)

FDA data resources