Pure Enrichment Pepulse
Pure Enrichment Pepulse is a Class II device made by Bear Down Consulting, listed in FDA GUDID since 19 Oct 2016 (UDI-DI B311PEPULSE0), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB311PEPULSE0 | Date19 Oct 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Pure Enrichment
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- PEPULSE
- Primary DI / UDI-DI
- B311PEPULSE0
- FDA product code
- NUH
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).
- Wireless Pain Relieve Device Model: LT5018C by Shenzhen Dongdixin Technology Co., Ltd.
- Digital TENS Unit by Shenzhen Eapply Technology Co., Ltd.
- OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 by Well-Life Healthcare, Inc.
- OTC COMBO TENS/EMS SYSTEM by Well-Life Healthcare, Inc.
- Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 by HIVOX BIOTEK INC.
- Low-frequency Multi-function physiotherapy instrument by Shenzhen Osto Technology Co., Ltd.
- OTC Electrical Stimulator (MT9001), OTC TENS Device (LT3060) by Shenzhen Dongdixin Technology Co., Ltd.
- PAINMASTER MCT PATCH by Newmark, Inc.
- MSLS6QF TENS/PMS Device by Self Doctor Care, LLC
- EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only by Easywell Biomedicals, Inc.