FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

STAGE ZERO AIR FLOTATION BED

K Number: K905053 · Decision Nov 26, 1990
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
15
Review Days
18

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Basic Information

Device Name
STAGE ZERO AIR FLOTATION BED
K Number
K905053
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5170
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Lake Medical Products, Inc.
Date Received
November 8, 1990
Decision Date
November 26, 1990
Product Code
IOQ
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IOQ Bed, Flotation Therapy, Powered

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Other Clearances by Lake Medical Products, Inc.

K Number Device Name
K943162 LAKE STAGEZERO(TM) AIR FLOTATION BED
K922730 LAKE OSTOMY CARE SET
K901835 LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)
K902508 LAKE MALE EXTERNAL CATHETERIZATION KIT
K902121 LAKE GASTROSTOMY TUBE
K884127 LAKE N/G FEEDING TUBE
K884128 LAKE N/G EXTENSION SET
K883610 LAKE FOLEY CATHETERIZATION TRAY
K880578 LAKE DISPOSABLE PROBE COVER
K875383 LAKE CATHETER CARE KITS (MODIFICATION)
Search all 15 clearances from Lake Medical Products, Inc. →