Unite Medical® PWB6061-M-S
GUDID 00850063323024
Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.
Unite Medical, LLC
Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot| Primary Device ID | 00850063323024 |
| NIH Device Record Key | e24e0364-506d-4b9a-855f-8bdd645cd7e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unite Medical® |
| Version Model Number | Short Walking Boot - Pneumatic (Medium) |
| Catalog Number | PWB6061-M-S |
| Company DUNS | 117553945 |
| Company Name | Unite Medical, LLC |
| 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 | true |
| 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 | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net | |
| Phone | 833-868-6483 |
| info@unitemedical.net |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850063323024 [Primary] |
FDA Product Code
| ITW | Joint, Ankle, External Brace |
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 | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
On-Brand Devices [Unite Medical®]
| 00850012035640 | The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft |
| 00850012035633 | The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft |
| 00850012035626 | The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft |
| 00850012035619 | The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft |
| 00850012035589 | The Unite Medical® Lumbar Sacral Orthosis is a universal, lightweight spinal orthosis offering |
| 00850012035572 | The Unite Medical® Lumbar Sacral Orthosis is a universal, lightweight spinal orthosis offering |
| 00850012035503 | The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic an |
| 00850012035497 | The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic an |
| 00850012035480 | The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic an |
| 00850012035473 | The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic an |
| 00850012035466 | The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic an |
| 00850012035459 | The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic an |
| 00850012035442 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035428 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035411 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035404 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035398 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035381 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035374 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035367 | The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament |
| 00850012035329 | The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspen |
| 00850012035251 | The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament |
| 00850012035244 | The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament |
| 00850012035138 | The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament j |
| 00850012035121 | The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pa |
| 00850063323048 | Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and |
| 00850063323031 | Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and |
| 00850063323024 | Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and |
| 00850063323017 | Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and |
| 00850063323000 | Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and |
| 00850052096953 | Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and c |
| 00850052096946 | Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and c |
| 00850052096939 | Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and c |
| 00850052096922 | Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and c |
| 00850052096915 | Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and c |
| 00850012035312 | The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold th |
Trademark Results [Unite Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNITE MEDICAL 97280509 not registered Live/Pending |
Unite Medical, LLC 2022-02-23 |
 UNITE MEDICAL 97280501 not registered Live/Pending |
Unite Medical, LLC 2022-02-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.