ODSTOCK MEDICAL LIMITED

Address:SALISBURY DISTRICT HOSPITAL,SALISBURY Wiltshire,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Muscle, Powered (IPF) (1) Stimulator, Neuromuscular, External Functional (GZI) (1)

Premarket Exempt

Clear

ODFS Pace XL - 05060195470441 Catalog Number : 00-001-0019

Device Description : Single channel, transcutaneous neuromuscular stimulator for relief of dropped fo Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also cleared for gait re-education and similar applications plus physical therapy uses.

Device Class : 2

Duns Number: 347303674

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

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