Electronic Pulse Massager
510(k) K131933
Electronic Pulse Massager is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Gurin Products, LLC, cleared under FDA 510(k) K131933 on 20 Dec 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131933 | Date20 Dec 2013 | StatusActive |
Official records
- FDA 510(k) database K131933
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NUH
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).
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- Painmaster MCT Patch by Newmark, Inc.
- THERAPEUTIC MASSAGE COMPANION by Endurance Therapeutics
- Nu-beca Transcutaneous Electrical Nerve Stimulation by Nu-Beca & Maxcellent Co.
- Tens & Ems Device by Shenzhen Jian Feng Electronic Technology Co., Ltd.
- Electronic Pulse Stimulator by Beijing Choice Electronic Technology Co., Ltd.
- OTC TENS Device, Model PTS-IV by Counter Scientific Development (GZ) Limited