Pain Buddy
by Biomedical Life Systems, Inc.
510(k) K102051
Pain Buddy is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Biomedical Life Systems, Inc., cleared under FDA 510(k) K102051 on 29 Jul 2011, 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 | NumberK102051 | Date29 Jul 2011 | StatusActive |
Official records
- FDA 510(k) database K102051
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- Withdrawn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
Devices cleared under K102051
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Rebound Health | KBTR6 / Rebound Health | 10857771003016 | — | On the market |
| Rebound Rebound Health | KBTR / Rebound Health | 00857771003019 | — | On the market |
| Rebound Rebound Sport | KBTS / Rebound Sport | 00857771003101 | — | On the market |
| Rebound Sport | KBTS6 / Rebound Sport | 10857771003108 | — | On the market |
Similar devices
Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).
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- Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) by Hong Qiangxing (Shenzhen) Electronics Limited
- Patch-TEA (Model TRI-21) by Transtimulation Research Inc
- HI-DOW-XP by HI-DOW INTERNATIONAL INC.
- Neck Care Therapy, Model: SYK 509B by Shenzhen Osto Technology Co., Ltd.
- TENS7000 Rechargeable (Model:TENS7000 Rechargeable) by Chongqing Rob Linka Science and Technology Co., Ltd.
- Focus TENS Therapy, Model PM710-M/-L by Omron Healthcare, Inc.