HIVOX Spopad EMS SP-911, SP-921
FDA 510(k) K192264 · Hivox Biotek, Inc.
510(k) numberK192264
Submission
- Device name
- HIVOX Spopad EMS SP-911, SP-921
- Applicant
- Hivox Biotek, Inc.
New Taipei City, TW - Received
- August 21, 2019
- Decision date
- November 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
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| K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2NUH · Special | 06/11/2022SE |
| K211403 | HIVOX OTC Electrical Stimulator, FT610-BNUH · Traditional | 10/15/2021SE |
| K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2NUH · Traditional | 03/10/2021SE |
| K190347 | HIVOX OTC Electrical StimulatorNUH · Special | 03/15/2019SE |
| K171803 | HIVOX OTC Electrical StimulatorNUH · Traditional | 11/29/2017SE |
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Questions and answers
When was HIVOX Spopad EMS SP-911, SP-921 cleared by the FDA?
HIVOX Spopad EMS SP-911, SP-921 (K192264) received a 510(k) decision of Substantially Equivalent on November 8, 2019, 79 days after the submission was received.
What is the product code of K192264?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.