Maxistim
FDA 510(k) K955031 · Life-Tech Intl., Inc.
510(k) numberK955031
Submission
- Device name
- Maxistim
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- November 2, 1995
- Decision date
- December 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KOI – Stimulator, Nerve, Peripheral, Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…KOI · Special | Senzime AB | 05/22/2026SE |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091)KOI · Traditional | MIPM Mammendorfer Institut für Physik und… | 10/21/2025SE |
| K243339 | WiTOFKOI · Traditional | Idmed | 06/23/2025SE |
| K242525 | iTOF®KOI · Traditional | Nerbio Medical Software Platforms, Inc. | 12/05/2024SE |
| K220530 | Tetragraph Neuromuscular Transmission MonitorKOI · Traditional | Senzime AB | 08/17/2022SE |
| K220976 | Life Scope PT BSM-1700 Series Bedside MonitorKOI · Special | Nihon Kohden Corporation | 07/21/2022SE |
| K212434 | Neuromuscular Transmission Monitor TOF3DKOI · Traditional | MIPM Mammendorfer Institut für Physik und… | 05/05/2022SE |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…KOI · Special | Nihon Kohden Corporation | 12/29/2021SE |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…KOI · Traditional | Nihon Kohden Corporation | 05/02/2021SE |
| K192958 | TwitchView SystemKOI · Special | Blink Device Company | 04/02/2020SE |
More from Blink Device Company
| 510(k) | Device | Decision |
|---|---|---|
| K001129 | Prolong, Models PL50, PL100, PL150CAZ · Traditional | 07/06/2000SE |
| K954505 | Ez StimKOI · Traditional | 12/10/1996SE |
| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
| K953451 | Uropump Tube & Damping ChamgerFEN · Traditional | 10/05/1995SE |
| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | 11/18/1993SE |
Questions and answers
When was Maxistim cleared by the FDA?
Maxistim (K955031) received a 510(k) decision of Substantially Equivalent on December 10, 1996, 404 days after the submission was received.
What is the product code of K955031?
The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.