| Device Type ID | 5749 |
| Device Name | Battery, Replacement, Rechargeable |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MOQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5749 |
| Device | Battery, Replacement, Rechargeable |
| Product Code | MOQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Unintended System Motion | 448 |
Fail-Safe Problem | 441 |
Device Inoperable | 108 |
Failure To Charge | 88 |
Device Operates Differently Than Expected | 76 |
Overheating Of Device | 59 |
Charging Problem | 36 |
Battery Charger | 31 |
Battery | 17 |
Break | 17 |
Failure To Power Up | 16 |
Noise, Audible | 15 |
Device Displays Incorrect Message | 13 |
Battery Problem | 12 |
Mechanical Problem | 12 |
Crack | 11 |
Fluid Leak | 9 |
Mechanical Jam | 9 |
Detachment Of Device Component | 7 |
Defective Component | 7 |
Device Stops Intermittently | 6 |
Defective Device | 6 |
Loose Or Intermittent Connection | 5 |
Housing | 5 |
Unexpected Shutdown | 5 |
Loss Of Power | 5 |
Device Operational Issue | 5 |
Output Below Specifications | 5 |
Smoking | 5 |
No Display / Image | 4 |
LED (Light Emitting Diode) | 4 |
Component Falling | 4 |
Temperature Problem | 3 |
Material Deformation | 3 |
Bent | 3 |
Melted | 3 |
Connection Problem | 3 |
Premature Discharge Of Battery | 2 |
Component Missing | 2 |
Fire | 2 |
Port | 2 |
Power Module | 2 |
Corroded | 2 |
Power Conditioning Problem | 2 |
Vibration | 2 |
Flare Or Flash | 2 |
Power Problem | 2 |
Device Damaged By Another Device | 2 |
Separation Failure | 2 |
Failure To Deliver Energy | 2 |
Device Emits Odor | 2 |
Locking Mechanism | 2 |
Torn Material | 2 |
Detachment Of Device Or Device Component | 2 |
No Fail-Safe Mechanism | 1 |
Unintended Head Motion | 1 |
Difficult To Position | 1 |
Device Slipped | 1 |
Aborted Charge | 1 |
Moisture Damage | 1 |
Low Battery | 1 |
Delayed Charge Time | 1 |
Switch, Push Button | 1 |
Charger | 1 |
Component Incompatible | 1 |
Computer Operating System Problem | 1 |
Device Subassembly | 1 |
Sticking | 1 |
Dent In Material | 1 |
Failure Of Device To Self-Test | 1 |
Handpiece | 1 |
Failure To Advance | 1 |
Unstable | 1 |
Holder | 1 |
Fracture | 1 |
Fan | 1 |
Difficult To Open Or Close | 1 |
Power Supply | 1 |
Circuit Failure | 1 |
| Total Device Problems | 1565 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Pro-Dex Inc | II | Mar-11-2016 |
| 2 | The Anspach Effort, Inc. | II | Jul-05-2016 |
| 3 | The Anspach Effort, Inc. | II | Jun-15-2016 |