510(k) K781964

COMPRESSION DEVICES, LIMB by Alba-Waldensian, Inc. — Product Code IRP

K781964 is an FDA 510(k) premarket notification submitted by Alba-Waldensian, Inc. for the device "COMPRESSION DEVICES, LIMB". The FDA issued a decision of Substantially Equivalent on December 12, 1978. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Alba-Waldensian, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1978
Date Received
November 20, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type