DEVICE: ActiPatch (00851329005203)
Device Identifier (DI) Information
ActiPatch
077
In Commercial Distribution
168
Bioelectronics Corporation
077
In Commercial Distribution
168
Bioelectronics Corporation
Back , Knee, Muscle and Joint 7 day trial
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 35169 | Hand-held deep-tissue electromagnetic stimulator |
A battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K152432 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Temperature: between 5 and 40 Degrees Celsius |
| Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
97401496-47f3-4e49-8843-1e3ab056c1ad
March 04, 2021
2
July 23, 2020
March 04, 2021
2
July 23, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
301-874-4890
skoneru@bielcorp.com 301-874-4890
brice@bielcorp.com 301-874-4890
rcarusone@bielcorp.com
skoneru@bielcorp.com 301-874-4890
brice@bielcorp.com 301-874-4890
rcarusone@bielcorp.com