Identity
- Trade Name
- OrthoCor Medical FDA UDI
- Generic Name
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Activ8 Shoulder FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851979007565 FDA UDI
- 510(k) Number
- K241395 FDA UDI
- FDA Product Code
- ILX FDA UDIIRT FDA UDI
- GMDN Term
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5290 FDA UDI890.5740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Hand-held deep-tissue electromagnetic stimulator
OrthoCor Medical by Caerus Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held deep-tissue electromagnetic stimulator.
- Nexstim NBS Orange Head Tracker — Nexstim Oyj · Class II
- ActiPatch — BIOELECTRONICS CORPORATION · Class II
- BEMER Basic-Set Evo — Bemer Int. AG · Class II
- Healthpal — Xiamen Healthpal Electronic Co., Ltd · Class II
- BEMER Therapy Systems — Bemer Int. AG · Class II
- LS Pro Systems — WELLNESS WITHOUT LIMITS LLC · Class II
- KT RECOVERY+ WAVE — BIOELECTRONICS CORPORATION · Class II
- Bemer Therapy System — Bemer Int. AG · Class II
Cleared under the same submission
K241395 also covers:
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
- OrthoCor Medical — Caerus Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Caerus Corporation
Sources (1)
- FDA UDI f62a1b83-6550-44c1-a522-88b493f2805d 34 fields · synced Jun 8, 2026