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

ZIMMER ELECTRICAL MUSCLE STIMULATOR

K Number: K803064 · Decision Dec 31, 1980
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
376
Review Days
27

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K Number
K803064
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5850
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Zimmer, Inc.
Date Received
December 4, 1980
Decision Date
December 31, 1980
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

Similar 510(k) Clearances

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

View all

Other Clearances by Zimmer, Inc.

K Number Device Name
K261683 Augment Off-Axis Instrument System
K260831 Z1 Hip System
K251840 Zimmer® Persona® Personalized Knee System
K260182 Avenir® Müller Stem; Avenir Complete™ Hip System
K253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
K253566 Affixus Retrograde Femoral Nailing System
K253189 Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
K252623 G7® Revision Acetabular System
K251098 Identity Revision Humeral Stems
K251906 Z1 Hip System
Search all 376 clearances from Zimmer, Inc. →