Hi-Dow-Xp
510(k) K102598
Hi-Dow-Xp is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Hi-Dow International, Inc., cleared under FDA 510(k) K102598 on 13 May 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 | NumberK102598 | Date13 May 2011 | StatusActive |
Official records
- FDA 510(k) database K102598
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- Withdrawn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 K102598
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 | |||
|---|---|---|---|---|
| COPPER Fit JQ-5C-07A | JQ-5C-07A | 00851640007573 | — | On the market |
| ECHO JQ-5C-D | JQ-5C-D | 00851640007276 | — | On the market |
| ECHO JQ-5C-R | JQ-5C-R | 00851640007320 | — | On the market |
| Hi-Dow JQ-5C-E | JQ-5C-E | 00851640007016 | — | On the market |
| Hi-Dow JQ-5C-T | JQ-5C-T | 00851640007474 | — | On the market |
| HiDow JQ-5C-07A | JQ-5C-07A | 00851640007498 | — | On the market |
| HiDow JQ-5C-C | JQ-5C-C | 00851640007030 | — | On the market |
| HiDow JQ-5C-C | JQ-5C-C | 00851640007023 | — | On the market |
| HiDow JQ-5C-E | JQ-5C-E | 00851640007009 | — | On the market |
| HiDow JQ-5C-N | JQ-5C-N | 00851640007153 | — | On the market |
| HiDow JQ-5C-N | JQ-5C-N | 00851640007146 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007368 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007108 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007344 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007115 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007092 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007337 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007351 | — | On the market |
| HiDow JQ-5C-R | JQ-5C-R | 00851640007085 | — | On the market |
| HiDow JQ-5C-S | JQ-5C-S | 00851640007078 | — | On the market |
| HiDow JQ-5C-S | JQ-5C-S | 00851640007313 | — | On the market |
| HiDow JQ-5C-S | JQ-5C-S | 00851640007054 | — | On the market |
| HiDow JQ-5C-S | JQ-5C-S | 00851640007061 | — | On the market |
| HiDow JQ-5C-S | JQ-5C-S | 00851640007306 | — | On the market |
| HiDow JQ-5C-S | JQ-5C-S | 00851640007047 | — | On the market |
| HiDow JQ-5C-Y | JQ-5C-Y | 00851640007177 | — | On the market |
| HiDow JQ-5C-Y-RECEIVER | JQ-5C-Y-RECEIVER | 00851640007245 | — | On the market |
| Hidow SuperTens JQ-5C-W | JQ-5C-W | 00851640007269 | — | On the market |
| HiDow, SuperTens JQ-5C-W | JQ-5C-W | 00851640007283 | — | On the market |
| HiDow, TrueStim JQ-5C-N-RECEIVER | JQ-5C-N-RECEIVER | 00851640007160 | — | On the market |
| NAMIRSA JQ-5C-R | JQ-5C-R | 00851640007443 | — | On the market |
| Pain Remedy C05W | C05W | 00782944027007 | — | No longer on the market |
| PainAway Pro RTLAGF-900 | RTLAGF-900 | 00822383543727 | — | No longer on the market |
| PainAway Pro RTLAGF-920 | RTLAGF-920 | 00822383549415 | — | No longer on the market |
| PainAway Pro RTLAGF-940 | RTLAGF-940 | 00822383549460 | — | On the market |
| PainAway Pro RTLAGF-950 | RTLAGF-950 | 00822383549439 | — | No longer on the market |
| PainPod JQ-5C-07A | JQ-5C-07A | 00810093080014 | — | On the market |
| PainPod JQ-5C-B | JQ-5C-B | 09351609000023 | — | On the market |
| PainPod JQ-5C-C | JQ-5C-C | 00810093080854 | — | On the market |
| PainPod JQ-5C-C | JQ-5C-C | 00799439774018 | — | No longer on the market |
| PainPod JQ-5C-M | JQ-5C-M | 00851640007511 | — | On the market |
| PainPod JQ-5C-M | JQ-5C-M | 00799439774025 | — | No longer on the market |
| PRO-TECH JQ-5C-E | JQ-5C-E | 00851640007221 | — | On the market |
| PRO-TECH JQ-5C-S | JQ-5C-S | 00851640007214 | — | On the market |
| Somacare JQ-5C-C | JQ-5C-C | 00851640007504 | — | On the market |
| TenStim JQ-5C-R | JQ-5C-R | 00851640007375 | — | On the market |
| TenStim JQ-5C-S-12 | JQ-5C-S-12 | 00851640007450 | — | On the market |
| TrueStim JQ-5C-J | JQ-5C-J | 00851640007139 | — | On the market |
| TrueStim JQ-5C-J | JQ-5C-J | 00851640007122 | — | On the market |
| TrueStim JQ-5C-Y | JQ-5C-Y | 00851640007207 | — | On the market |
Similar devices
Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).
- HEATING TENS/EMS, FT-810R by HIVOX BIOTEK INC.
- DOLPHIN NEUROSTIM OTC by Acumed Medical, Ltd.
- TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) by Dongguan Bohuikang Technology Co., Ltd
- Transcutaneous Electrical Nerve Stimulator Model: ST-304 by SHENZHEN FUTURE ELECTRONIC CO., LTD
- Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 by Ningbo Medkinetic Medical Device Co., Ltd.
- PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER by Prospera Corporation
- Maxpower Relief by Omron Healthcare, Inc.
- Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS with Menstrual Relief Stimulator by Well-Life Healthcare, Inc.
- OTC TENS for Arm and Leg Pain Relief, Model WL-2407 by Well-Life Healthcare, Inc.
- Noodle by POURANG BRAL, DDS, LLC