| Primary Device ID | 04719879644715 |
| NIH Device Record Key | dd3ea07f-6651-4311-9229-d6a315586a30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfytopia |
| Version Model Number | EP42 |
| Company DUNS | 003944628 |
| Company Name | Comfytopia, Inc. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04719879644715 [Primary] |
| MRI | Orthosis, Truncal/Orthosis, Limb |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-13 |
| Device Publish Date | 2023-12-05 |
| 04719879645651 | BB31 Low Back Armor Wrap Airy 3D Fixation DesignBlack L-size |
| 04719879645644 | BB31 Low Back Armor Wrap Airy 3D Fixation DesignBlack M-size |
| 04719879645637 | BB31 Low Back Armor Wrap Airy 3D Fixation DesignBlack S-size |
| 04719879645606 | BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayL-size |
| 04719879645590 | BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayM-size |
| 04719879645583 | BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayS-size |
| 04719879645446 | KP40 Knee Patella Fulcrum Wrap Easyfit w/Cushion Tube |
| 04719879645439 | KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey XL-Size |
| 04719879645408 | KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey S-Size |
| 04719879645361 | KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey XL-Size Pair |
| 04719879645354 | KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey L-Size Pair |
| 04719879645347 | KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey M-Size Pair |
| 04719879645330 | KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey S-Size Pair |
| 04719879645323 | EE91 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayL-size Pair |
| 04719879645316 | EE91 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayM-size Pair |
| 04719879645309 | EE91 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayS-size Pair |
| 04719879645064 | ES10 Elbow Fulcrum Wrap Comfort fit Pink |
| 04719879645057 | ES10 Elbow Fulcrum Wrap Comfort fit Gary |
| 04719879645026 | WS10 Wrist Fulcrum Wrap Easy fit Pink |
| 04719879645019 | WS10 Wrist Fulcrum Wrap Easy fit Gray |
| 04719879645002 | WS10 Wrist Fulcrum Wrap Easy fit Black |
| 04719879644173 | SE21 Arm & Thigh Trimmer |
| 04719879644128 | FP30 Ankle Fulcrum wrap Black S/M |
| 04719879644043 | MS61 Maternity Belt Fulcrum Wrap Easy Fit & Soft Pink |
| 04719879644012 | KP30 Knee Fulcrum Wrap Ergonomic Stabilizer |
| 04719879644005 | FS10 Ankle Fulcrum Wrap Comfort fit Pink S/M |
| 04719879643992 | FS10 Ankle Fulcrum Wrap Comfort Fit Pink L/XL |
| 04719879643978 | FS10 Ankle Fulcrum Wrap Comfort Fit Gray S/M |
| 04719879643961 | FS10 Ankle Fulcrum Wrap Comfort Fit Gray L/XL |
| 04719879643947 | FS10 Ankle Fulcrum Wrap Comfort Fit Black S/M |
| 04719879643923 | FS10 Ankle Fulcrum Wrap Comfort Fit Black L/XL |
| 04719879643909 | FP30 Ankle Fulcrum wrap Black L/XL |
| 04719879643855 | ES10 Elbow Fulcrum Wrap Comfort fit Black |
| 04719879643848 | EP40 Tennis Elbow Fulcrum Wrap Easy fit w/Cushion PadGray |
| 04719879643824 | EP30 Elbow Fulcrum Wrap Ergonomic Splint |
| 04719879643718 | WP30 Wrist Fulcrum Wrap Ergonomic Cushion Splint |
| 04719879643657 | TP30 Thumb Fulcrum Wrap Ergonomic Splint |
| 04719879643633 | SE22 Waist trimmer Wrap Comfort Fit Trimmer Black S/M-size |
| 04719879643619 | SE22 Waist trimmer Wrap Comfort Fit Trimmer Black L/XL-size |
| 04719879643596 | SE20 Waist trimmer wrap Enhancement |
| 04719879643572 | KS10 Knee Fulcrum Wrap Comfort Fit Gray |
| 04719879643541 | KS10 Knee Fulcrum Wrap Comfort fit Black |
| 04719879643527 | KS10 Knee Fulcrum Wrap Comfort fit Pink |
| 04719879642872 | KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size |
| 04719879642520 | KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray XL-size |
| 04719879642513 | KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray L-size |
| 04719879642506 | KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray M-size |
| 04719879642490 | KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray S-size |
| 04719879642391 | KB30 Knee Fulcrum Wrap Dual Splints Stablizer w/Fixation Pad |
| 04719879642049 | MS90 Pelvis Belt Fulcrum Wrap Comfy & UltraSoft BeigeL/XL-size |