← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

JOW — Sleeve, Limb, Compressible

DEVICE CLASS
Class II
REGULATION
21 CFR 870.5800
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
12
510(K)/PMA CLEARANCES
510k: 12
0
RECALL ENTRIES

Recent clearances

K253386Vistar Medical Supplies Co., Ltd. · 510k2026-06-25
K250242Guangzhou Longest Medical Technology Co., Ltd. · 510k2026-04-24
K254267Mego Afek , Ltd. · 510k2026-02-24
K250974Bio Compression Systems, Inc. · 510k2025-12-12
K250190Shenzhen Comen Medical Instruments Co.,Ltd · 510k2025-12-08
K251466Wellell, Inc. · 510k2025-10-28
K251446Manamed, LLC · 510k2025-09-17
K251086Biotab, LLC · 510k2025-08-18

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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