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510(k) K944329

BACK SPECIALIST by Health Care Mfg., Inc. — Product Code INQ

K944329 is an FDA 510(k) premarket notification submitted by Health Care Mfg., Inc. for the device "BACK SPECIALIST". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code INQ (Table, Powered), a Class I device regulated under 21 CFR 890.3760. Health Care Mfg., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1995
Date Received
September 6, 1994
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 Health Care Mfg., Inc.

  • K022737 — HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC (October 22, 2002)
  • K022667 — HCMI X-RAY (October 22, 2002)
  • K952441 — LEGEND (June 19, 1995)
  • K951323 — VH-2000 (June 7, 1995)
  • K951382 — HLT 406 (June 1, 1995)
  • K944699 — ATT-300 (May 26, 1995)

Other clearances for product code INQ

  • K960334 — CARDON PHYSICAL THERAPY TABLE MODEL R27116 (February 13, 1996)
  • K960332 — CARDON PHYSICAL THERAPY TABLE MODEL R28598 (February 13, 1996)
  • K960336 — CARDON PHYSICAL THERAPY TABLE MODEL R27645 (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)
  • K952359 — THE HILL ADJUSTABLE HA90C (June 22, 1995)
  • K952356 — THE HILL ADJUSTABLE COUNTERSTRAIN TABLE (June 22, 1995)

FDA data resources