Pelvic Floor Stimulator (Intrelief PFE)
Easymed Instruments Co., Ltd.
EASYMED INSTRUMENTS CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004049909 | 3004049909 | EASYMED INSTRUMENTS CO., LTD. | 1 | N | 2026-01-01 | 3/F-6/F, Block A, No.4 Fengxin Road, Fengxiang Industrial District Daliang, Shunde, Foshan Guangdong CN 528300 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 21758 | 1245470244 | K241899 | Pelvic Floor Stimulator (Intrelief PFE) | KPI | 2024-11-27 |
| 21758 | 1324407964 | K211263 | Intrelief | NUH | 2021-12-30 |
| 21758 | 2061595601 | K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | BXN | 2016-05-13 |
| 21758 | 1178205073 | K143430 | SmartTENS | NUH | 2015-05-29 |
| 21758 | 1910312245 | K140168 | EASYSTIM TN28_OTC | NUH | 2014-08-28 |
| 21758 | 1829982595 | K131222 | AMPCARE ESP THERAPY SYSTEM | IPF | 2013-10-31 |
| 21758 | 1004896430 | K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | BXN | 2013-03-28 |
| 21758 | 1817827726 | K120054 | ULTIMA NEO | GZJ | 2012-06-05 |
| 21758 | 1240010069 | K073386 | JOINT STIM, MODEL 1000 | NYN | 2008-07-30 |
| 21758 | 1203224828 | K050921 | EASYSTIM NMS-28 | IPF | 2005-12-12 |
| 21758 | 2010762249 | K040253 | EASY MED TN-28 C | GZJ | 2004-04-08 |
| 21758 | 1111784891 | ||||
| 21758 | 1240010069 | ||||
| 21758 | 1829982595 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Intrelief PFE - Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
2026-05-05
KGL-1400-F - KGL-1400-F is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
2021-11-17
Parasym - Parasym is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2021-11-17
KGL-1400-M - KGL-1400-M is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
2021-11-15
LogiSTIM - LogiSTIM TN-11 is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2016-12-31
IntelliSTIM - IntelliSTIM BE-28T is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2016-12-31
MT-11 - MT-11 is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2017-12-31
IntelliSTIM - IntelliSTIM BE-28E is an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion.
2016-12-31
MKIII - MKIII is an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion.
2016-12-31
J Sport Plus - J Sport Plus is an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion
2016-12-31
iTENS - iTENS is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
2024-01-18
IF-4 MultiWave - EMS stands for Electrical Neuromuscular Stimulator. The IF-4 MultiWave EMS system is indicated for:• Relaxation of muscle spasm;• Increasing local blood circulation and muscle re-education;• Prevention or retardation of disuse atrophy;• Prevention of venous thrombosis of the calf muscles immediately after surgery;• Maintaining or increasing range of motion.IF stands for Interferential Stimulation. The IF-4 MultiWave IF system is indicated for:• Symptomatic relief of chronic intractable pain.
2024-01-19
Ultima Combo - Ultima Combo is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or post operative pain and an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion.
2021-11-17
Relief Combo - Relief Combo is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or post operative pain and an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion.
2021-11-17
Intrelief Combo - Intrelief Combo is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
2021-11-15
Ultima NEO - TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:• Relaxation of muscle spasm;• Increasing local blood circulation and muscle re-education;• Prevention or retardation of disuse atrophy;• Prevention of venous thrombosis of the calf muscles immediately after surgery;• Maintaining or increasing range of motion.MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:• Symptomatic relief of chronic intractable pain.
2021-11-15
TRi-WAVE - TENS stands for Transcutaneous Electrical Nerve Stimulation. The TRi-WAVE TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.EMS stands for Electrical Neuromuscular Stimulator. The TRi-WAVE EMS system is indicated for:• Relaxation of muscle spasm;• Increasing local blood circulation and muscle re-education;• Prevention or retardation of disuse atrophy;• Prevention of venous thrombosis of the calf muscles immediately after surgery;• Maintaining or increasing range of motion.IF stands for Interferential Stimulation. The TRi-WAVE IF system is indicated for:• Symptomatic relief of chronic intractable pain.
2021-11-15
NDGen - TENS stands for Transcutaneous Electrical Nerve Stimulation. The NDGen TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.MIC stands for Microcurrent Stimulation. The NDGen MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.IF stands for Interferential Stimulation. The NDGen IF system is indicated for:• Symptomatic relief of chronic intractable pain.
2021-11-15
Activ 8 - Activ 8 is an EMS (Electrical Neuromuscular Stimulator), which is indicated for: 1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion.
2021-09-15
Ampcare - The Ampcare ES powered muscle stimulator is indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
2016-12-31
TENS U5 - TENS U5 is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2021-11-15
Ultima 20 - Ultima 20 is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2021-11-15
TN-20 - TN-20 is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
2021-11-15
J-stim - The J-Stim external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated withosteoarthritis of the knee and for overall improvement of the knee.The J-Stim is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
2021-11-15
Ultima 3T+ - Ultima 3T+ is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2021-11-15
TENS AA - TENS AA is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2016-12-31
PowerTENS - PowerTENS is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
2016-12-31
MMI-Micro - MMI-Micro is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
2016-12-31