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510(k) K922965

TUMBLE FORMS TRISTANDER by Tumble Forms — Product Code INW

K922965 is an FDA 510(k) premarket notification submitted by Tumble Forms for the device "TUMBLE FORMS TRISTANDER". The FDA issued a decision of Substantially Equivalent on July 13, 1992. 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
July 13, 1992
Date Received
June 19, 1992
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

Other clearances for product code INW

  • K944308 — JAMES LECKEY FREE STANDER (December 22, 1994)
  • K944307 — JAMES LECKEY PRONE STANDER (December 22, 1994)
  • K943975 — EURO TECH PLATINUM CHIROPRACTIC TABLE (September 29, 1994)
  • 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)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)

FDA data resources