TTS2800
FDA 510(k) K895161 · Henley Intl.
510(k) numberK895161
Submission
- Device name
- TTS2800
- Applicant
- Henley Intl.
Sugar Land, TX, US - Received
- August 22, 1989
- Decision date
- October 30, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve StimulatorGZJ · Traditional | Algiamed Technologies USA, Inc. | 05/28/2026SE |
| K252767 | actiTENS miniGZJ · Traditional | Sublimed | 01/16/2026SE |
| K252236 | CP Relief Wand Rx - TENS/NMESGZJ · Special | N & C Holdings, LLC | 08/15/2025SE |
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
| K241228 | TENSWaveGZJ · Abbreviated | Zynex Medical Officer | 08/27/2024SE |
| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | Oriental Inspiration Limited | 04/19/2024SE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 01/24/2023SE |
| K212618 | iRelieve Microcurrent Pain Relief SystemGZJ · Traditional | Fast Track Technologies, Inc. | 09/14/2022SE |
| K213802 | StimOnTM Pain Relief System (GM2439)GZJ · Traditional | Gimer Medical Co., Ltd. | 08/26/2022SE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
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| K926314 | Hydra Fitness Model 311 Total PowerISD · Traditional | 03/18/1994SE |
| K926313 | Computerized Testing and Exercise SystemsBXB · Traditional | 02/04/1994SE |
| K915864 | Monotrode Cutaneous ElectrodeGXY · Traditional | 07/21/1993SE |
| K922036 | Sonopuls 591IMG · Traditional | 06/29/1993SE |
| K926316 | True-Trac, StratusJFB · Traditional | 03/24/1993SE |
| K920983 | Sonopuls 590IMI · Traditional | 03/09/1993SE |
Questions and answers
When was TTS2800 cleared by the FDA?
TTS2800 (K895161) received a 510(k) decision of Substantially Equivalent on October 30, 1989, 69 days after the submission was received.
What is the product code of K895161?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.