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

IPOS G.L.P. SYSTEM

K Number: K833868 · Decision Nov 28, 1983
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
8
Review Days
21

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Basic Information

Device Name
IPOS G.L.P. SYSTEM
K Number
K833868
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.3500
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Ipos Luneburg
Date Received
November 7, 1983
Decision Date
November 28, 1983
Product Code
KFX
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
KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External

Similar 510(k) Clearances

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

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Other Clearances by Ipos Luneburg

K Number Device Name
K834143 NYLON COMPRESSION STUMP SHEATH
K831690 IPOS ANTI-ADDUCTUS SHOE
K802977 IPOCARBON STRETCH STOCKINETTE
K802976 CARBONACRYL
K800749 IPOCON 7
K800716 ORTHOTIC LEG GAIT CORRECTOR DEVICE
K800715 OHC DYNAMIC CLUB FOOT BRACE