Home / 510(k) Clearances / K882229

510(k) K882229

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS by Biologics Intl., Inc. — Product Code IOQ

K882229 is an FDA 510(k) premarket notification submitted by Biologics Intl., Inc. for the device "AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 16, 1988. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Biologics Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1988
Date Received
May 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
Submission Type

Other clearances by Biologics Intl., Inc.

  • K823353 — CARCINO-CEK (December 14, 1982)
  • K812060 — BI-ASO SLIDE TEST (August 13, 1981)
  • K811374 — BI-CRP LATEX TEST (June 12, 1981)
  • K811375 — BI-RA SLIDE TEST (June 12, 1981)
  • K800605 — ANA LATEX SLIDE TEST (April 2, 1980)
  • K791609 — BE-SURE (October 2, 1979)
  • K791607 — BETA-CELL (September 24, 1979)
  • K790898 — PREG-TEX (July 30, 1979)

Other clearances for product code IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources