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510(k) K963620

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS by 9th Wave, Inc. — Product Code FNM

K963620 is an FDA 510(k) premarket notification submitted by 9th Wave, Inc. for the device "9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 7, 1997. 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
January 7, 1997
Date Received
September 10, 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.

  • K963626 — 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS (November 26, 1996)
  • 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