Submission Details
| 510(k) Number | K203847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 31, 2020 |
| Decision Date | May 07, 2021 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K203847 - Reprocessed Tri Pulse Compression Garment
(FDA 510(k) Clearance)
May 2021
Decision
127d
Days
Class 2
Risk
K203847 is an FDA 510(k) clearance for the Reprocessed Tri Pulse Compression Garment. This device is classified as a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW).
Submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on May 7, 2021, 127 days after receiving the submission on December 31, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
Device Classification
| Product Code | JOW — Sleeve, Limb, Compressible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5800 |
Similar Devices — JOW Sleeve, Limb, Compressible
All 348
K254267 · Mego Afek , Ltd.
· Feb 2026
K250974 · Bio Compression Systems, Inc.
· Dec 2025
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd
· Dec 2025
K251466 · Wellell, Inc.
· Oct 2025
K251446 · Manamed, LLC
· Sep 2025
K251086 · Biotab, LLC
· Aug 2025