510(k) K830793

PATIENT GUIDED ELBOW & SHOULDER EXERC by Richard'S Medical Equip., Inc. — Product Code BXB

K830793 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "PATIENT GUIDED ELBOW & SHOULDER EXERC". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
March 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type