510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMVClass I

Orthosis, Limb, For Back Pain

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

PMV is the FDA product code for Orthosis, Limb, For Back Pain, a class I device type, regulated under 21 CFR 890.3475. FDA's definition for this code reads: "Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PMV
Device name
Orthosis, Limb, For Back Pain
FDA definition
Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PMV

By decision year
1 clearance under product code PMV with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PMV by decision year
YearClearances
20161

Applicants with the most clearances

Product code PMV
Applicants holding the most 510(k) clearances under product code PMV
ApplicantClearances
Natures Pillows, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order