FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY

K Number: K920270 · Decision Mar 2, 1992
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
1
Review Days
41

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Basic Information

Device Name
CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY
K Number
K920270
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.5380
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Sports Medical Synergy
Date Received
January 21, 1992
Decision Date
March 2, 1992
Product Code
BXB
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
BXB Exerciser, Powered

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