PlayMakar PRO-500

GUDID 00856675008168

PLAYMAKAR SPORT MUSCLE STIMULATOR

PLAYMAKAR INC.

Arthritis TENS system

• Primary Device ID: 00856675008168
• NIH Device Record Key: bfd00cee-ed14-4b6d-ad6f-cdbdcad671b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlayMakar
• Version Model Number: PRO-500
• Catalog Number: PRO-500
• Company DUNS: 081212270
• Company Name: PLAYMAKAR INC.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8337529625
• Email: IAM@PlayMakar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856675008045 [Primary]
GS1	00856675008151 [Package]; Contains: 00856675008045; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	00856675008168 [Package]; Contains: 00856675008151; Package: Master Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182581

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-02-22

On-Brand Devices [PlayMakar]

• 20856675008278: PLAYMAKAR SPORT SNAP ELECTRODES REFILL KIT
• 10856675008264: PLAYMAKAR SPORT SNAP ELECTRODES, 2" x 4", 2/Pack
• 10856675008257: PLAYMAKAR SPORT SNAP ELECTRODES, 2" x 2", 4/Pack
• 00856675008236: PLAYMAKAR PRO SELF ADHESIVE ELECTRODES
• 20856675008056: PLAYMAKAR PRO EXPANDABLE WIRELESS PODS
• 00856675008168: PLAYMAKAR SPORT MUSCLE STIMULATOR
• 00856675008212: PLAYMAKAR PRO SELF ADHESIVE ELECTRODES, 2.75" X 4", 2/PACK
• 00856675008205: PLAYMAKAR PRO SELF ADHESIVE ELECTRODES, 2.75" X 2.75", 4/PACK
• 10856675008011: PLAYMAKAR MINI WIRELESS TENS UNIT
• 00856675008007: PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM
• 00856675008755: PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM (4 Pods)
• 00856675008724: PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM (2 Pods)