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

ELECTRICAL NEURO-MUSCULAR STIMULATOR

K Number: K840895 · Decision Apr 24, 1984
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
71
Review Days
57

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Basic Information

Device Name
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K Number
K840895
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5850
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Richards Medical Co., Inc.
Date Received
February 27, 1984
Decision Date
April 24, 1984
Product Code
IPF
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
IPF Stimulator, Muscle, Powered

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Other Clearances by Richards Medical Co., Inc.

K Number Device Name
K896106 ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
K900628 MODULAR HIP SYSTEM
K896580 UNI-POLAR HEAD
K895241 INTRAMEDULLARY HIP SCREW
K884824 TRICON-M TOTAL KNEE SYSTEM
K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
Search all 71 clearances from Richards Medical Co., Inc. →