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

A PHYSIOTHERAPY APPARATUS

K Number: K902803 · Decision Feb 6, 1991
Classifications
1
FEI Numbers
423
Registration Numbers
423
Same Product Code
227
Applicant Total
2
Review Days
224

Basic Information

Device Name
A PHYSIOTHERAPY APPARATUS
K Number
K902803
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5500
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
GRACE RIVER ENT., INC.
Date Received
June 27, 1990
Decision Date
February 6, 1991
Product Code
ILY
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
ILY Lamp, Infrared, Therapeutic Heating

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K Number Device Name
K891277 PATIENT EXAMINATION GLOVES (LATEX)