STIMFIT
GUDID 07640174840007
Electrical Muscle Stimulator for muscle conditioning.
Valmed SA
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 07640174840007 |
| NIH Device Record Key | 33586904-3c8e-4361-84ef-894d2c4f1729 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STIMFIT |
| Version Model Number | 1.03 |
| Company DUNS | 484275094 |
| Company Name | Valmed SA |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640174840007 [Primary] |
| GS1 | 07640174840014 [Package] Package: box [1 Units] In Commercial Distribution |
| GS1 | 07640174840021 [Package] Package: box [1 Units] In Commercial Distribution |
| GS1 | 07640174840052 [Package] Contains: 07640174840014 Package: Master carton [20 Units] In Commercial Distribution |
| GS1 | 07640174840069 [Package] Contains: 07640174840021 Package: Master carton [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031611
FDA Product Code
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-11-28 |
Trademark Results [STIMFIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIMFIT 86614892 5214530 Live/Registered |
BODYLOGIC WEARABLES LLC 2015-04-30 |
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