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510(k) K952092

ERGOMAT 8000 SYSTEM by Ergo-Air, Inc. — Product Code FNM

K952092 is an FDA 510(k) premarket notification submitted by Ergo-Air, Inc. for the device "ERGOMAT 8000 SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 1995. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Ergo-Air, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1995
Date Received
May 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type

Other clearances by Ergo-Air, Inc.

  • K954162 — ERGOSEAT SYSTEM (October 30, 1995)
  • K952093 — ERGOMAT 5000 SYSTEM (July 26, 1995)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K974319 — MIGHTY AIR (January 22, 1998)
  • K974070 — PHYSIO/1000 (January 6, 1998)
  • K972549 — SIMPULSE (November 18, 1997)
  • K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (November 7, 1997)
  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
  • K965207 — RID-DECUBE II (August 21, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)

FDA data resources