ManaFlexx 00850998008034
GUDID 00850998008034
ManaFlexx is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
MANAMED INC
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 00850998008034 |
| NIH Device Record Key | 453a1c4c-37a7-4f42-8073-8777241188da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaFlexx |
| Version Model Number | MF0001-RX |
| Catalog Number | 00850998008034 |
| Company DUNS | 084042331 |
| Company Name | MANAMED INC |
| 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 | true |
| Lot Batch | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850998008034 [Primary] |
FDA Product Code
| IPF | Stimulator, Muscle, Powered |
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 | 2019-10-23 |
| Device Publish Date | 2017-10-02 |
Devices Manufactured by MANAMED INC
| 00850998008102 - ManaMed | 2024-06-10 Reusable universal size compression calf garment, increases venous blood flow to help prevent deep vein thrombosis. |
| 00810113681092 - ManaMed Inc | 2024-06-03 Reusable extra large size compression calf garment, increases venous blood flow to help prevent deep vein thrombosis. |
| 00810113683218 - ManaMed | 2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl |
| 00850998008089 - ManaMed | 2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl |
| 00850998008423 - ManaMed | 2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl |
| 00850998008904 - ManaMed | 2024-05-08 The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or aid in the prevention of DVT. T |
| 00810113682655 - ManaMed Inc | 2023-09-05 ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold t |
| 00810113682662 - ManaMed Inc | 2023-09-05 ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold th |
Trademark Results [ManaFlexx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MANAFLEXX 90556549 not registered Live/Pending |
MANAMED INC. 2021-03-02 |
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