AccessGUDID - DEVICE: Power Knee (05690967556815)

GUDID

Device Identifier (DI) Information

Brand Name: Power Knee
Version or Model: PK220007
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PK220007
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690967556815
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 139280028 *Terms of Use

Device Description: POWER KNEE BATTERY CHARGER NA

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?
64722	Motorized external knee prosthesis	An active-power electromechanical device, with rechargeable batteries, which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on a motorized mechanism which exerts significant forces on the user to actively propel the user, especially during stance phase, for support during a variety of activities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISW	ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 0 and 45 Degrees Celsius
Handling Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d9a9dbe-0593-4e76-aaa4-246b7124ca53
Public Version Date: July 01, 2025
Public Version Number: 2
DI Record Publish Date: May 16, 2018