VQ ORTHOCARE

GUDID 00817717020241

BIONICARE KNEE SYSTEM RIGHT 2XL/3XL

V Q Orthocare

Arthritis transcutaneous electrical joint stimulation system

• Primary Device ID: 00817717020241
• NIH Device Record Key: 9ac96d9f-a2db-48a0-8cbf-8537ed7a534b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VQ ORTHOCARE
• Version Model Number: 55-95004-401
• Company DUNS: 601204902
• Company Name: V Q Orthocare
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817717020241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030332

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2017-07-05

On-Brand Devices [VQ ORTHOCARE]

• 00817717021668: BIONICARE NIGHT-WRAP SYSTEM DEMO
• 00817717020449: OACTIVE OA CUSTOM KNEE ORTHOSIS RIGHT
• 00817717020432: OACTIVE OA CUSTOM KNEE ORTHOSIS LEFT
• 00817717020425: OACTIVE OA OTS KNEE ORTHOSIS RIGHT TALL
• 00817717020418: OACTIVE OA OTS KNEE ORTHOSIS LEFT TALL
• 00817717020401: OACTIVE OA OTS KNEE ORTHOSIS RIGHT STANDARD
• 00817717020395: OACTIVE OA OTS KNEE ORTHOSIS LEFT STANDARD
• 00817717020388: ECLIPSE EXT WIDE REPL PAD SET VQ
• 00817717020371: ECLIPSE WIDE REPL PAD SET VQ
• 00817717020364: ECLIPSE EXT REPL PAD SET VQ
• 00817717020357: ECLIPSE REPL PAD SET VQ
• 00817717020340: ECLIPSE WIDE BACK PANEL VQ GRAY
• 00817717020333: ECLIPSE WIDE BACK PANEL VQ PALE BLUE
• 00817717020326: ECLIPSE EXT CERV COLLAR VQ WITH EXTRA PAD SET GRAY
• 00817717020319: ECLIPSE EXT CERV COLLAR VQ WITH EXTRA PAD SET PALE BLUE
• 00817717020302: ECLIPSE EXT CERV COLLAR VQ GRAY
• 00817717020296: ECLIPSE EXT CERV COLLAR VQ PALE BLUE
• 00817717020289: ECLIPSE CERV COLLAR VQ WITH EXTRA PAD SET GRAY
• 00817717020272: ECLIPSE CERV COLLAR VQ WITH EXTRA PAD SET PALE BLUE
• 00817717020265: ECLIPSE CERV COLLAR VQ GRAY
• 00817717020258: ECLIPSE CERV COLLAR VQ PALE BLUE
• 00817717020241: BIONICARE KNEE SYSTEM RIGHT 2XL/3XL
• 00817717020234: BIONICARE KNEE SYSTEM RIGHT L/XL
• 00817717020227: BIONICARE KNEE SYSTEM RIGHT S/M
• 00817717020210: BIONICARE KNEE SYSTEM LEFT 2XL/3XL
• 00817717020203: BIONICARE KNEE SYSTEM LEFT L/XL
• 00817717020197: BIONICARE KNEE SYSTEM LEFT S/M
• 00817717020180: BIONICARE KNEE SYSTEM 3XL
• 00817717020173: BIONICARE KNEE SYSTEM 2XL
• 00817717020166: BIONICARE KNEE SYSTEM XL
• 00817717020159: BIONICARE KNEE SYSTEM LARGE
• 00817717020142: BIONICARE KNEE SYSTEM MEDIUM
• 00817717020135: BIONICARE KNEE SYSTEM SMALL
• 00817717020128: BIONICARE NIGHT-WRAP SYSTEM
• 00817717020111: BIONICARE HAND SYSTEM WHOLESALE LARGE RIGHT
• 00817717020104: BIONICARE HAND SYSTEM WHOLESALE LARGE LEFT
• 00817717020098: BIONICARE HAND SYSTEM WHOLESALE MEDIUM RIGHT
• 00817717020081: BIONICARE HAND SYSTEM WHOLESALE MEDIUM LEFT
• 00817717020074: BIONICARE HAND SYSTEM WHOLESALE SMALL RIGHT
• 00817717020067: BIONICARE HAND SYSTEM WHOLESALE SMALL LEFT
• 00817717020050: BIONICARE HAND SYSTEM INTERNATIONAL LARGE RIGHT
• 00817717020043: BIONICARE HAND SYSTEM INTERNATIONAL LARGE LEFT
• 00817717020036: BIONICARE HAND SYSTEM INTERNATIONAL MEDIUM RIGHT
• 00817717020029: BIONICARE HAND SYSTEM INTERNATIONAL MEDIUM LEFT
• 00817717020012: BIONICARE HAND SYSTEM INTERNATIONAL SMALL RIGHT
• 00817717020005: BIONICARE HAND SYSTEM INTERNATIONAL SMALL LEFT
• 00817717021811: Avid IF2 INTERFERENTIAL STIMULATION SYSTEM
• 00817717021682: BIONICARE HAND SYSTEM INTERNATIONAL
• 00817717021675: BIONICARE HAND SYSTEM US
• 00817717022580: BIONICARE ALIGN CUSTOM PB HD R