ComfyHealth

GUDID 04719879644562

BRACOO BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayXL-size

Comfy Health Group Co., Ltd.

Static magnetic orthopaedic orthosis

• Primary Device ID: 04719879644562
• NIH Device Record Key: fa43e27a-88a4-44a4-89a9-b0fbc0dbbc86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfyHealth
• Version Model Number: BP61
• Company DUNS: 658202517
• Company Name: Comfy Health Group Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719879644562 [Primary]

FDA Product Code

• ISR: Band Or Belt, Pelvic Support

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-18
• Device Publish Date: 2025-07-10

On-Brand Devices [ComfyHealth]

• 04719879646580: BRACOO WB51 Wrist Armor Wrap 3D Ergo Fixation & Breathable Black Free size
• 04719879646566: BRACOO TB50 Finger Armor wrap 3D Ergo Fixation & Breathable Support Black XS size
• 04719879646177: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch Black XL-size Pair
• 04719879646160: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch Black L-size Pair
• 04719879646153: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch Black M-size Pair
• 04719879646146: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch Black S-size Pair
• 04719879646139: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayXL-size Pair
• 04719879646122: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayL-size Pair
• 04719879646115: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayM-size Pair
• 04719879646108: BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayS-size Pair
• 04719879646009: BRACOO KP32 Knee Airy Wrap Breathable & Ergo Cushion Pad
• 04719879644562: BRACOO BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayXL-size
• 04719879642889: BRACOO FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL
• 04719879641875: BRACOO SE23 Waist trimmer Wrap Comfort Fit & Wicking Performance Black SIZE:L/XL
• 04719879641868: BRACOO SE23 Waist trimmer Wrap Comfort Fit & Wicking Performance Black SIZE:S/M