FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ActiPatch
DI: 00851329005241
·
Model: 088
·
BioElectronics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ActiPatch
- Primary DI
- 00851329005241
- Version / Model
- 088
- Catalog Number
- 103-4
- Company Name
- BioElectronics Corporation
- Labeler DUNS
- 101591571
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-09
- Public Version
- 2
- Public Version Date
- 2026-03-20
- Public Version Status
- Update
- Public Device Record Key
- 1231d403-2403-4419-ab60-7f732382daf4
- Distribution End Date
- 2021-06-09
Device Description
ActiPatch Knee Pain Therapy Device 5 pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | Physical Medicine | 890.5290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851329005241 | GS1 |
Customer Contacts
- Phone
- 3018744890
- [email protected]
- Phone
- 3018744890
- [email protected]
- Phone
- 3018744890
- [email protected]