MetaFlex
GUDID D481454
The MetaFlex therapy glove combines compression for improved circulation & grip strengthening to increase hand function, mobility, and strength.
ATS Innovations
Compression/pressure glove| Primary Device ID | D481454 |
| NIH Device Record Key | 8a8d76da-70fc-4411-b6f0-be08defdf55f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MetaFlex |
| Version Model Number | 13437 |
| Company DUNS | 118657416 |
| Company Name | ATS Innovations |
| Device Count | 2 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D481454 [Primary] |
| HIBCC | G342134370 [Direct Marking] |
FDA Product Code
| ILH | Splint, Hand, And Components |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2023-03-28 |
On-Brand Devices [MetaFlex]
| L012023 | The MetaFlex therapy glove combines compression for improved circulation & grip strengthening to |
| D481454 | The MetaFlex therapy glove combines compression for improved circulation & grip strengthening to |
Trademark Results [MetaFlex]
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