Combo Electrotherapy Device— 510(k) K231440
Substantially EquivalentShenzhen Roundwhale Technology Co. , Ltd.
FDA 510(k) clearance K231440 for Combo Electrotherapy Device, Substantially Equivalent on 2023-11-03. Applicant: Shenzhen Roundwhale Technology Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code IPF
view allMore clearances from Shenzhen Roundwhale Technology Co. , Ltd.
view all- K231423 — Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
- K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005 +4 more
- K222252 — Self-adhesive Electrode
- K192087 — Combo Electrotherapy Device
- K181688 — R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
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