AccessGUDID - DEVICE: ODFS Pace XL (05060195470441)

GUDID

Device Identifier (DI) Information

Brand Name: ODFS Pace XL
Version or Model: 1.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-001-0019
Company Name: ODSTOCK MEDICAL LIMITED

Primary DI Number: 05060195470441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 347303674 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35725	Gait-enhancement electrical stimulation system, external	An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, Muscle, Powered
GZI	Stimulator, Neuromuscular, External Functional

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171396	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 922ec1aa-5358-4c95-9862-49b8a895956e
Public Version Date: September 24, 2018
Public Version Number: 1
DI Record Publish Date: August 22, 2018