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FDA 510(k)

Unicare (K-UNICARE-USA)

K-Number: K231053 · 2023-08-18

ApplicantTenscare, Ltd.
Decision Date2023-08-18
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Unicare (K-UNICARE-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231053. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unicare (K-UNICARE-USA)?

Unicare (K-UNICARE-USA) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Tenscare, Ltd.. The 510(k) number is K231053.

When did Unicare (K-UNICARE-USA) receive FDA 510(k) clearance?

Unicare (K-UNICARE-USA) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231053.

Who is the listed applicant for Unicare (K-UNICARE-USA)?

The FDA 510(k) record lists Tenscare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unicare (K-UNICARE-USA)?

The FDA product code for Unicare (K-UNICARE-USA) is NUH.

Other records listing Tenscare, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232441Unipro (K-UNIPRO-US)K230926Ova+ (K-OVAP-USA)K230983Unicare (K-UNICARE-USA)K200694Perfect EMSK191312Perfect PFE

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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