Medical Device Manufacturer · TW , New Taipei City

Wellell, Inc.

2 submissions · 2 cleared · Since 2025
2
Total
2
Cleared
0
Denied

Wellell, Inc. — FDA 510(k) Submissions

Wellell, Inc. has submitted 2 FDA 510(k) premarket notifications since 2025, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sleeve, Limb, Compressible, Ventilator, Non-continuous (respirator) . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
K251466 · JOW Sleeve, Limb, Compressible · Cardiovascular
Oct 2025 168d
WiZARD 520 Full Face Mask
K243023 · BZD Ventilator,... · Anesthesiology
May 2025 238d
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