Physio-Stim
GUDID 18257200078943
Physio-Stim Bone Growth Stimulator
ORTHOFIX INC.
Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator| Primary Device ID | 18257200078943 |
| NIH Device Record Key | f624cecf-7b16-4c46-8b01-99d960a45bc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Physio-Stim |
| Version Model Number | 3202A |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200078943 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P850007
FDA Product Code
| LOF | Stimulator, bone growth, non-invasive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Physio-Stim]
| 18257200079315 | Physio-Stim Bone Growth Stimulator |
| 18257200079308 | Physio-Stim Bone Growth Stimulator |
| 18257200079285 | Physio-Stim Bone Growth Stimulator |
| 18257200079278 | Physio-Stim Bone Growth Stimulator |
| 18257200079254 | Physio-Stim Bone Growth Stimulator |
| 18257200079247 | Physio-Stim Bone Growth Stimulator |
| 18257200079223 | Physio-Stim Bone Growth Stimulator |
| 18257200079216 | Physio-Stim Bone Growth Stimulator |
| 18257200079193 | Physio-Stim Bone Growth Stimulator |
| 18257200079186 | Physio-Stim Bone Growth Stimulator |
| 18257200079162 | Physio-Stim Bone Growth Stimulator |
| 18257200079155 | Physio-Stim Bone Growth Stimulator |
| 18257200079117 | Strap, Model 3315 Replacement |
| 18257200079100 | Strap, 3313/3314 Replacement |
| 18257200079056 | Physio-Stim Bone Growth Stimulator |
| 18257200079049 | Physio-Stim Bone Growth Stimulator |
| 18257200079032 | Physio-Stim Bone Growth Stimulator |
| 18257200079025 | Physio-Stim Bone Growth Stimulator |
| 18257200079018 | Physio-Stim Bone Growth Stimulator |
| 18257200079001 | Physio-Stim Bone Growth Stimulator |
| 18257200078998 | Physio-Stim Bone Growth Stimulator |
| 18257200078981 | Physio-Stim Bone Growth Stimulator |
| 18257200078974 | Physio-Stim Bone Growth Stimulator |
| 18257200078967 | Physio-Stim Bone Growth Stimulator |
| 18257200078950 | Physio-Stim Bone Growth Stimulator |
| 18257200078943 | Physio-Stim Bone Growth Stimulator |
Trademark Results [Physio-Stim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHYSIO-STIM 74209479 1701625 Live/Registered |
AMEI TECHNOLOGIES, INC. 1991-10-04 |
 PHYSIO-STIM 73438979 not registered Dead/Abandoned |
American Medical Electronics, Inc. 1983-08-10 |
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