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

DIGITAL GRIP/PINCH STRENGTH METOR

K Number: K850697 · Decision May 14, 1985
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
35
Applicant Total
70
Review Days
82

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Basic Information

Device Name
DIGITAL GRIP/PINCH STRENGTH METOR
K Number
K850697
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.1240
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Chattanooga Group, Inc.
Date Received
February 21, 1985
Decision Date
May 14, 1985
Product Code
LBB
Advisory Committee
Orthopedic
Review Advisory Committee
NE
Third Party
N

Classifications

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

Product Code Device Name
LBB Dynamometer, Ac-Powered

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K982321 VECTRA STIM MODELS 200 AND 400
K982829 FORTE, MODEL CPS ULTRASOUND
K982828 FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982830 FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
K980718 PARA-CARE
K974497 INTELECT
K973024 INTELECT LEGEND ULTRASOUND
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