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510(k) K963626

9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS by 9th Wave, Inc. — Product Code FNM

K963626 is an FDA 510(k) premarket notification submitted by 9th Wave, Inc. for the device "9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. 9th Wave, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
September 11, 1996
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 9th Wave, Inc.

  • K963620 — 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS (January 7, 1997)
  • K963677 — 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD (November 26, 1996)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K974319 — MIGHTY AIR (January 22, 1998)
  • K972022 — ZAK-2000 (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