FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthoCor Medical
DI: 00851979007572
·
Model: Activ8 Elbow
·
Caerus Corp.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OrthoCor Medical
- Primary DI
- 00851979007572
- Version / Model
- Activ8 Elbow
- Company Name
- Caerus Corp.
- Labeler DUNS
- 021776723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-10
- Public Version
- 1
- Public Version Date
- 2025-03-18
- Public Version Status
- New
- Public Device Record Key
- a754e6e6-5e6b-4b62-8591-ddf5059889e8
Device Description
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | Physical Medicine | 890.5290 | 2 |
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 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 | 00851979007572 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241395 | 000 |