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510(k) K933621

HILO TABLE by Spinalight, Inc. — Product Code INQ

K933621 is an FDA 510(k) premarket notification submitted by Spinalight, Inc. for the device "HILO TABLE". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code INQ (Table, Powered), a Class I device regulated under 21 CFR 890.3760. Spinalight, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
July 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Powered
Device Class
Class I
Regulation Number
890.3760
Review Panel
PM
Submission Type

Other clearances by Spinalight, Inc.

  • K172536 — Atlas Percussion Adjusting Instrument (June 20, 2018)
  • K001476 — TORQUE INSTRUMENT, MODEL 8500 (August 4, 2000)
  • K955540 — HAND HELD ATLAS INSTRUMENT (March 4, 1996)
  • K946258 — MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT (November 20, 1995)
  • K945954 — MODELS 4100 AND 4300 MULTITHERAPY (January 19, 1995)
  • K933622 — FLEXION DISTRACTION TABLE (January 7, 1994)

Other clearances for product code INQ

  • K960334 — CARDON PHYSICAL THERAPY TABLE MODEL R27116 (February 13, 1996)
  • K960336 — CARDON PHYSICAL THERAPY TABLE MODEL R27645 (February 13, 1996)
  • K960332 — CARDON PHYSICAL THERAPY TABLE MODEL R28598 (February 13, 1996)
  • K960196 — TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 (February 7, 1996)
  • K953621 — EVT-3300 (November 14, 1995)
  • K953622 — PTT 6200 ELEVATION THERAPY TABLE (September 11, 1995)
  • K952357 — THE HILL ADJUSTABLE PODIATRY MODEL (July 6, 1995)
  • K951419 — FLEX D-4000 (June 30, 1995)
  • K952358 — THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE (June 22, 1995)
  • K951955 — CARDON PHYSICAL THERAPY TABLE MODEL:R40194 (June 22, 1995)

FDA data resources