CP Relief Wand Rx - TENS/NMES
FDA 510(k) clearance K252236 · decided 2025-08-15
Clearance details
- K-number
- K252236
- Device name
- CP Relief Wand Rx - TENS/NMES
- Applicant
- N & C Holdings, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-07-17
- Decision date
- 2025-08-15
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Jefferson City, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STIMPOD NMS460 Nerve Stimulator (K252712) | Algiamed Technologies USA, Inc. | 2026-05-28 |
| actiTENS mini (K252767) | Sublimed | 2026-01-16 |
| Unipro (K-UNIPRO-US) (K232441) | Tenscare, Ltd. | 2024-08-30 |
| TENSWave (K241228) | Zynex Medical Officer | 2024-08-27 |
| Electrical Neuromuscular Stimulator, Cure Trio (K233046) | Oriental Inspiration Limited | 2024-04-19 |
| Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (K222879) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 |
| iRelieve Microcurrent Pain Relief System (K212618) | Fast Track Technologies, Inc. | 2022-09-14 |
| StimOnTM Pain Relief System (GM2439) (K213802) | Gimer Medical Co., Ltd. | 2022-08-26 |
| Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (K220578) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 |
| TENS device-EmeTerm 2, Model: YF-ZTY-E2 (K220503) | Wat Medical Technology, Inc. | 2022-04-23 |
| Transcutaneous Electrical Nerve Stimulator (K202893) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 |
| TrueRelief Device (K202186) | Truerelief | 2021-03-23 |
Recalls involving this device
No recalls on record reference this clearance.