FDA product code LYG: Massager, Therapeutic, Manual
LYG is the FDA product code for massager, therapeutic, manual. It is a Class I device, regulated under 21 CFR 890.5660 and reviewed by the Physical Medicine panel. FDA has cleared 13 510(k) submissions under LYG, from 12 different applicants. The average 510(k) review took 194 days (median 115).
Classification
| Field | Value |
|---|---|
| Device name | Massager, Therapeutic, Manual |
| Device class | Class I |
| Regulation | 21 CFR 890.5660 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LYG clearance
Top LYG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferguson Medical | 2 | 1988-07-21 |
| Shippert Medical Technologies Corp. | 1 | 1996-11-26 |
| Mckenna & Cuneo | 1 | 1996-01-29 |
| Eight Corners, Inc. | 1 | 1995-09-01 |
| Alain Machtelinckx | 1 | 1994-07-12 |
7 more applicants have LYG clearances. See the full list in Caduvo.
Most recent LYG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963704 | Shippert Medical Technologies Corp. | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | 1996-11-26 | 71 |
| K936312 | Mckenna & Cuneo | MANUAL MASSAGE ROLLER | 1996-01-29 | 794 |
| K952043 | Eight Corners, Inc. | BACK MASSAGER | 1995-09-01 | 123 |
| K930613 | Alain Machtelinckx | HOOKING SYSTEM | 1994-07-12 | 522 |
| K936148 | Arocep Enterprises , Ltd. | STRESS HANDLER | 1994-04-21 | 115 |
Recalls for LYG devices
openFDA lists no recalls for product code LYG.
Frequently asked questions
What is FDA product code LYG?
LYG is the FDA product code for massager, therapeutic, manual. It is a Class I device, regulated under 21 CFR 890.5660 and reviewed by the Physical Medicine panel.
What device class is LYG?
Class I, regulation 21 CFR 890.5660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYG?
Across 13 cleared submissions the average was 194 days from receipt to decision (median 115).
Which companies have the most LYG clearances?
Ferguson Medical (2); Shippert Medical Technologies Corp. (1); Mckenna & Cuneo (1); Eight Corners, Inc. (1); Alain Machtelinckx (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LYG
- Run a recall and safety report across every LYG manufacturer
- Watch product code LYG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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