FDA product code MOQ: Battery, Replacement, Rechargeable
MOQ is the FDA product code for battery, replacement, rechargeable. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under MOQ, from 3 different applicants. The average 510(k) review took 94 days (median 70). FDA has posted 6 recalls for MOQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Battery, Replacement, Rechargeable |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MOQ clearance
Top MOQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vidacare Corporation | 1 | 2008-11-21 |
| Nordix, Inc. | 1 | 2001-11-13 |
| Alexander Mfg. Co. | 1 | 1998-04-02 |
Most recent MOQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081713 | Vidacare Corporation | VERTEBRAL ACCESS SYSTEM BY VIDACARE | 2008-11-21 | 157 |
| K013133 | Nordix, Inc. | NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 | 2001-11-13 | 55 |
| K980224 | Alexander Mfg. Co. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 | 1998-04-02 | 70 |
Recalls for MOQ devices
6 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-09-23.
| Year | Recalls |
|---|---|
| 2024 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system
Frequently asked questions
What is FDA product code MOQ?
MOQ is the FDA product code for battery, replacement, rechargeable. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is MOQ?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MOQ?
Across 3 cleared submissions the average was 94 days from receipt to decision (median 70).
Which companies have the most MOQ clearances?
Vidacare Corporation (1); Nordix, Inc. (1); Alexander Mfg. Co. (1).
Have MOQ devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2024-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MOQ
- Run a recall and safety report across every MOQ manufacturer
- Watch product code MOQ 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times