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510(k) K895444

THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION by Mcvicar Enterprises, Ltd. — Product Code INW

K895444 is an FDA 510(k) premarket notification submitted by Mcvicar Enterprises, Ltd. for the device "THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION". The FDA issued a decision of Substantially Equivalent on December 13, 1989. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1989
Date Received
September 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type

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  • K943974 — EURO TECH MARQUISE CHIROPRACTIC TABLE (September 29, 1994)
  • K940238 — TUMBLE FORMS JUNIOR TRISTANDER (March 7, 1994)
  • K932233 — ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (July 22, 1993)
  • K932238 — ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS (July 22, 1993)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)

FDA data resources