Revitive ProHealth 6302
GUDID 10858058005259
Neuromuscular Electrical Stimulation Device
ACTEGY LIMITED
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 10858058005259 |
| NIH Device Record Key | 3ca6d3c8-c122-469f-9370-2378dd0c4615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revitive ProHealth |
| Version Model Number | 5572AQ |
| Catalog Number | 6302 |
| Company DUNS | 735575941 |
| Company Name | ACTEGY LIMITED |
| 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 | 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
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858058005252 [Primary] |
| GS1 | 10858058005259 [Package] Contains: 00858058005252 Package: Outer carton [7 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152480
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-29 |
| Device Publish Date | 2021-01-21 |
Devices Manufactured by ACTEGY LIMITED
| 10858058005228 - Revitive Medic Coach | 2022-02-07 Neuromuscular Electrical Stimulation Device |
| 10858058005044 - Aerosure | 2021-05-12 |
| 05060217492130 - Revitive Electrode Body Pads | 2021-05-12 |
| 10858058005259 - Revitive ProHealth | 2021-01-29Neuromuscular Electrical Stimulation Device |
| 10858058005259 - Revitive ProHealth | 2021-01-29 Neuromuscular Electrical Stimulation Device |
| 10858058005235 - Revitive Medic | 2021-01-27 Neuromuscular Electrical Stimulation Device |
| 10858058005105 - Revitive Essential | 2020-10-02 Neuromuscular Electrical Stimulation Device |
| 10858058005181 - Revitive Medic Knee | 2020-10-02 Neuromuscular Electrical Stimulation Device |
| 05060217493588 - Revitive Arthritis Knee Pads | 2020-08-05 Revitive Arthritis Knee Pads |
Trademark Results [Revitive ProHealth]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVITIVE PROHEALTH 88847353 not registered Live/Pending |
Actegy Health Limited 2020-03-25 |
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