ActaStim-S
ActaStim-S Spine Fusion Stimulator - Shower Covers, Electrode
1manufacturer
11catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
Record
| Listed by | Theragen, Inc., United States |
|---|---|
| FDA product code | LOF |
| Device type | Stimulator, Bone Growth, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5870 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | P190030 |
| Record published | 2021-02-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 40 °C; Handling environment temperature 5 to 40 °C; Storage environment humidity 15 to 90 % RH; Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 700 to 1060 millibar; Storage environment atmospheric pressure 700 to 1060 millibar |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1101-0002 | In distribution | |
| 1101-0001-R | In distribution | |
| 4101-0002 | In distribution | |
| 1101-0001 | In distribution | |
| 1101-0003 | In distribution | |
| 1101-0000 | In distribution | |
| 1101-0016 | In distribution | |
| 1101-0007 | In distribution | |
| 4101-0000 | In distribution | |
| 4101-0001 | In distribution | |
| 1101-0006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pemf – Physio-Stim | Orthofix US LLC | 39 |
| Physio-Stim | Orthofix US LLC | 26 |
| Biomet EBI Bone Healing System | EBI, LLC | 24 |
| Biomet SpinalPak / OrthoPak | EBI, LLC | 18 |
| Orthofix Osteogenesis Stimulator | Orthofix US LLC | 16 |
| Xstim | Xstim Inc. | 11 |
| CMF | DJO, LLC | 8 |
| Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | EBI, LLC | 7 |
| Cervical-Stim | Orthofix US LLC | 7 |
| Biomet OrthoPak Non-invasive Bone Growth Stimulator System | EBI, LLC | 6 |
| Accelstim | Igea SPA | 6 |
| Spinal Stim | Orthofix US LLC | 6 |
Showing 12 of 21. All products under Stimulator, Bone Growth, Non-Invasive
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P210016 | 2025-01-17 | ManaFuse | Enovis |
| P230025 | 2024-11-12 | Xstim Spine Fusion Stimulator | Xstim Inc. |
| P790002 | 2022-11-23 | Biomet® OrthoPak Non-invasive Bone Growth Stimulator System | Ahp Eos Buyer, Inc. |
| P190030 | 2022-06-17 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. |
| P210035 | 2022-05-03 | AccelStimTM Bone Growth Stimulator | Orthofix US LLC |
| P850007 | 2018-08-22 | PhysioStim, SpinalStim | Orthofix SRL |
| P900009 | 2017-09-11 | EXOGEN Ultrasound Bone Healing System | Bioventus LLC |
| P850022 | 2015-09-09 | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR | Ahp Eos Buyer, Inc. |
| P030034 | 2009-09-11 | CERVICAL-STIM | Orthofix SRL |
| P910066 | 1997-01-03 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | DJO, LLC |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.