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

AQUA-PAD FOR MOIST OR DRY HEAT THERAPY

K Number: K890853 · Decision Apr 14, 1989
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
92
Applicant Total
3
Review Days
52

Basic Information

Device Name
AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
K Number
K890853
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5720
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
ATI
Date Received
February 21, 1989
Decision Date
April 14, 1989
Product Code
ILO
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
ILO Pack, Hot Or Cold, Water Circulating

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (ILO), ordered by most recent decision date.

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Other Clearances by ATI

K Number Device Name
K902344 ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
K890852 AQUA-BLANKET HYPER/HYPOHERMIA BLANKET